BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1402303 · Received June 16, 2009

    Report

    Report Number
    2015691-2009-10834
    Event Type
    Death
    Date Received
    June 16, 2009
    Date of Event
    April 15, 2009
    Report Date
    May 12, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND THE OPERATIVE REPORT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS. SEVERE PULMONARY FIBROSIS. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: PER DISCUSSION WITH OUR VP OF PRODUCT SAFETY, THERE IS NO EVIDENCE THAT OUR VALVES ARE RELATED TO CASES OF PULMONARY FIBROSIS. HE HAS DISASSOCIATED THIS DEVICE FROM THE EVENT, AND THEREFORE, THIS IS NO LONGER A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF LESS THAN 1 MONTH, DUE TO SEVERE PULMONARY FIBROSIS. PER THE OPERATIVE REPORT, THE VALVE WAS INITIALLY IMPLANTED TO CORRECT SEVERE AORTIC STENOSIS. "EXCELLENT SEATING OF THE VALVE WAS NOTED. EXCELLENT BIOPROSTHETIC LEAFLET MOBILITY WAS ALSO NOTED.....THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE CARDIOVASCULAR INTENSIVE CARE UNIT IN STABLE CONDITION." THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09C0445

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death