BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 10203214 · Received June 26, 2020

    Report

    Report Number
    2015691-2020-12310
    Event Type
    Death
    Date Received
    June 26, 2020
    Date of Event
    April 1, 2011
    Report Date
    June 1, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    510K: THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN SAPIEN XT AND SAPIEN 3: P110021, P130009 AND P140031. BIBLIOGRAPHY: ANDRES M PINEDA, M. J. ET AL (2020). TRANSCATHETER AORTIC VALVE REPLACEMENT FOR PATIENTS WITH SEVERE BICUSPID AORTIC STENOSIS. AMERICAN HEART JOURNAL, 105-112. THIS IS 5 OF 5 REPORTS BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NUMBERS: 2015691-2020-12305, 2015691-2020-12306, 2015691-2020-12307 AND 20205691-2020-12309. PATIENTS UNDERGOING THV PROCEDURES OFTEN HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. THEY MAY ALSO HAVE LIMITED CARDIAC RESERVE THAT CAN IMPAIR RECOVERY FROM THE PROCEDURE. AFTER THV PROCEDURES PATIENTS ARE CLOSELY MONITORED, WHICH INCLUDES ASSESSMENT OF DEVICE IMPLANTS. THERE ARE MANY POTENTIAL CAUSES FOR A PATIENT¿S DEATH FOLLOWING A CARDIAC SURGICAL PROCEDURE, INCLUDING POST-PROCEDURAL COMPLICATIONS UNRELATED TO THE DEVICE ITSELF, AND COMPLICATIONS RELATED TO CO-MORBIDITIES. WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE PATIENT¿S DEATH AND THE IMPLANTED VALVE. IN THIS CASE, PER ARTICLE, 3 PATIENTS IN THE SAPIEN GROUP EXPERIENCED CARDIOVASCULAR MORTALITY. THE CAUSE OF 30-DAY CARDIOVASCULAR MORTALITY IS UNKNOWN AS THE ARTICLE DID NOT PROVIDE DETAILED INFORMATION. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED IN THE ARTICLE. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A SINGLE-CENTER STUDY WAS PUBLISHED IN THE JOURNAL ARTICLE "TRANSCATHETER AORTIC VALVE REPLACEMENT FOR PATIENTS WITH SEVERE BICUSPID AORTIC STENOSIS". THE STUDY PERIOD WAS APRIL 2011 TO NOVEMBER 2016 AND COMPARED THE OUTCOMES WITH TRI-LEAFLET AORTIC VALVES (TAV) TREATED WITH TAVR. THE PRESENT ANALYSIS WAS LIMITED TO PATIENTS WHO UNDERWENT TREATMENT WITH THE COMMERCIALLY AVAILABLE BALLOON EXPANDABLE VALVE SYSTEM AND INCLUDED 232 PATIENTS TREATED WITH EDWARDS SAPIEN, SAPIEN XT OR SAPIEN 3. THE AIM OF THE STUDY WAS TO EVALUATE THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH BICUSPID AORTIC VALVE STENOSIS (BAV) AND COMPARED THEM WITH THOSE OF TRI-LEAFLET AORTIC VALVES (TAV). THIS COMPLAINT REPRESENTS THE 3 PATIENTS WHO SUFFERED 30-DAY CARDIOVASCULAR MORTALITY THAT OCCURRED IN THE BALLOON EXPANDABLE VALVE SYSTEM (SAPIEN GROUP) DURING THE STUDY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663379 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death