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Signals from Device Events
November 2019

Signals is a quarterly medical device adverse events newsletter.

Transcatheter Heart Valves (Examples)
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA. 
   Heart Valve Replacement / Transcatheter Heart Valve
  • A total of 33 Alternative Summary Reports (ASRs) were filed with the FDA from August 2018 through August 2019.
    • 15 ASRs reported 2,682 Deaths, which was 87% of all Deaths in 2018 & 2019
    • 18 ASRs reported 12,662 Injuries, which was 61% of all Injuries in 2018 & 2019

Heart Valve Replacements - Adverse Event Trend - Deaths

Heart Value Replacement - Adverse Event Trend - Injury


Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database
October 7, 2019 – JAMA Internal Medical – Authors: Lily Meier; Elizabeth Y. Wang, BA; Madris Tomes, MBA; Rita F. Redberg, MD, MSc
          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. 
          Although the FDA’s medical device reporting regulations require that device-user facilities report adverse events to the FDA, physician reporting is voluntary.3Adverse event datamay 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 TranscatheterValve Therapy registry submits reports to the FDA in summaries thatmay 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. View Full Article

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Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
October 8, 2019 - Mass Device Medical Network
          Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study.
          The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total of 10,558 adverse event reports related to Abbott’s MitraClip or Edwards’ Sapien 3 devices from the time the FDA approved them through December 2018. It was published as a research letter in the journal yesterday.
The researchers used an algorithm designed by Tomes to search adverse event reports using terms other than “death” that may also indicate that a death has occurred, including “expired,” “hospice,” “comfort care,” “passed away,” “died,” “autopsy,” “autopsied” and “comfort.”  View Full Article

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Deaths Linked to Transcatheter Valve Cases May Be 'Underreported'
October 15, 2019 - Medscape
          Deaths associated with some transcatheter valve-repair procedures may be underreported in a US Food and Drug Administration (FDA) adverse events database, leaving a misleading picture of the number of associated fatalities, a new report suggests.
          It found that 17.5% of deaths associated with the SAPIEN 3 (Edwards Lifesciences) transcatheter valve and 24.7% of those associated with MitraClip (Abbott Vascular) were misclassified as "injury" or "malfunction" events in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.  View Full Article

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