Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database | Valvular Heart Disease | JAMA Internal Medicine | JAMA Network
[Skip to Content]
[Skip to Content Landing]
1.
Dhruva  SS, Bero  LA, Redberg  RF.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.  JAMA. 2009;302(24):2679-2685. doi:10.1001/jama.2009.1899PubMedGoogle ScholarCrossref
2.
Barlas  S.  FDA flags inconsistent hospital reporting of medical device problems: hazy reporting rules beget confusion.  P T. 2017;42(2):97-115.PubMedGoogle Scholar
3.
US Food and Drug Administration. Mandatory reporting requirements: manufacturers, importers and device user facilities. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/default.htm. Updated May 2, 2019. Accessed August 29, 2019.
4.
Carroll  JD, Edwards  FH, Marinac-Dabic  D,  et al.  The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.  J Am Coll Cardiol. 2013;62(11):1026-1034. doi:10.1016/j.jacc.2013.03.060PubMedGoogle ScholarCrossref
5.
Device Events. https://www.deviceevents.com/. Accessed April 20, 2019.
6.
Jewett  C. Hidden FDA reports detail harm caused by scores of medical devices. Kaiser Health News. https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/. Published March 7, 2019. Accessed July 16, 2019.
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    1 Comment for this article
    Non-reporting of adverse events
    Harald Aanning, MD | Retired general surgeon
    Perhaps a contributing obstacle to obtaining accurate data on deaths from "injury or malfunction events" from medical devices is the lack of documentation of fatal medical/surgical complications on death certificates.

    I have not encountered a death certificate (or discharge diagnosis) that documents the specific complication causing a patient's death in my review of a dozen medical charts of fatalities from medical/surgical complications in my state.
    CONFLICT OF INTEREST: None Reported
    Research Letter
    October 7, 2019

    Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

    Author Affiliations
    • 1Bates College, Lewiston, Maine
    • 2School of Medicine, University of California, San Francisco
    • 3Device Events, York, Pennsylvania
    • 4Department of Medicine, University of California, San Francisco
    • 5Editor, JAMA Internal Medicine
    JAMA Intern Med. 2020;180(1):147-148. doi:10.1001/jamainternmed.2019.4030

    As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making. With less time for premarketing clinical studies, postmarketing data are the principal way adverse events and risks become apparent. Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up.1 The process of reporting adverse events is cumbersome, and reporting rates are low.2

    Although the FDA’s medical device reporting regulations require that device-user facilities report adverse events to the FDA, physician reporting is voluntary.3 Adverse event data may be recorded in registries such as the Transcatheter Valve Therapy database,4 which gathers national data on interventional cardiology devices. However, the Transcatheter Valve Therapy registry does not make its data publicly available, which limits its value. Instead, the Transcatheter Valve Therapy registry submits reports to the FDA in summaries that may omit redacted information and obscure important data. Publicly accessible adverse event reports are housed in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, where they are classified as malfunction, injury, or death events. We examined the misclassification of death reports for the Sapien 3 and MitraClip devices (high-risk interventional cardiac devices that were approved by the FDA in 2013 and 2015, respectively) within the MAUDE database.

    Methods

    We used the software Device Events,5 which collates adverse event reports from MAUDE in a more accessible format. We examined adverse event reports on the Sapien 3 and MitraClip devices from their respective approval dates through December 31, 2018. Device Events pulls directly from FDA raw data but in a user-friendly format with faster search times. The critical-events thesaurus within Device Events searches and identifies reports characterized as injuries and malfunctions for terms that indicate that a death may have occurred. We used the critical events thesaurus and search terms (Box) comprising synonyms for death, including expired and passed away, to gather reports in which a patient may have died but the event was misclassified as an injury or malfunction. Two authors (L.M. and E.Y.W.) independently analyzed the reports to determine if a death had in fact occurred. Owing to the use of publicly available deidentified data, the institutional review board at the University of California, San Francisco determined the study did not require approval.

    Box Section Ref ID
    Box.

    Search Terms

    • Expired

    • Hospice

    • Comfort care

    • Passed away

    • Died

    • Autopsy or autopsied

    • Comfort

    Results
    Sapien 3

    We found 9320 injury and malfunction reports for the Sapien 3 device and 1021 reports of deaths; 217 (2.3%) of the injury and malfunction reports also stated that the patient had died during or after the implantation of the device. In addition to directly using the word died, the most commonly used terms in these reports to describe the death of a patient were expired, passed away, and autopsy. Thus, misclassified reports made up 217 of 1238 (17.5%) total patient deaths.

    MitraClip

    We found 5323 injury and malfunction reports for the MitraClip device and 295 reports of deaths; 97 (1.8%) of the injury and malfunction reports also stated that the patient had died. Terms used in injury and malfunction reports to describe patient deaths included expired, hospice, and passed away. Thus, 97 of 392 (24.7%) patient deaths were misclassified as injury or malfunction events.

    Discussion

    We found a substantial misclassification of patient deaths in the FDA’s MAUDE database for the Sapien 3 and MitraClip devices, which resulted in the underreporting of deaths. Our findings raise concerns about the accuracy of adverse-event reports for high-risk devices. The results complement recent news reports that the FDA allowed device manufacturers to file reports of malfunctions in a hidden database, known as alternative summary reporting.6 Both the miscategorization of deaths in FDA adverse-event reporting and hidden adverse-events reports can lead to inaccurate public and physician perception of the safety of medical devices and can compromise informed decision-making. Given the increased reliance on postmarketing surveillance, improving the accuracy and clarity of adverse-event reporting should be a high priority for both the FDA and industry.

    Back to top
    Article Information

    Accepted for Publication: July 19, 2019.

    Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, University of California, San Francisco, 505 Parnassus Ave, Ste M1180, San Francisco, CA 94143-0124 (rita.redberg@ucsf.edu).

    Published Online: October 7, 2019. doi:10.1001/jamainternmed.2019.4030

    Author Contributions: Dr Redberg had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
    Study concept and design: Wang, Tomes, Redberg.
    Acquisition, analysis, or interpretation of data: Meier, Wang, Tomes.
    Drafting of the manuscript: Meier, Wang.
    Critical revision of the manuscript for important intellectual content: Wang, Tomes, Redberg.
    Statistical analysis: All authors.
    Administrative, technical, or material support: Tomes, Redberg.
    Study supervision: Redberg.

    Conflict of Interest Disclosures: Ms Tomes is the chief executive officer of Device Events. No other disclosures are reported.

    Disclaimer: Dr Redberg is editor of JAMA Internal Medicine but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

    References
    1.
    Dhruva  SS, Bero  LA, Redberg  RF.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.  JAMA. 2009;302(24):2679-2685. doi:10.1001/jama.2009.1899PubMedGoogle ScholarCrossref
    2.
    Barlas  S.  FDA flags inconsistent hospital reporting of medical device problems: hazy reporting rules beget confusion.  P T. 2017;42(2):97-115.PubMedGoogle Scholar
    3.
    US Food and Drug Administration. Mandatory reporting requirements: manufacturers, importers and device user facilities. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/default.htm. Updated May 2, 2019. Accessed August 29, 2019.
    4.
    Carroll  JD, Edwards  FH, Marinac-Dabic  D,  et al.  The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.  J Am Coll Cardiol. 2013;62(11):1026-1034. doi:10.1016/j.jacc.2013.03.060PubMedGoogle ScholarCrossref
    5.
    Device Events. https://www.deviceevents.com/. Accessed April 20, 2019.
    6.
    Jewett  C. Hidden FDA reports detail harm caused by scores of medical devices. Kaiser Health News. https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/. Published March 7, 2019. Accessed July 16, 2019.
    ×