BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2851776 · Received November 29, 2012

    Report

    Report Number
    2015691-2012-18730
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: RECORDS INDICATE THE PATIENT WAS DIAGNOSED WITH AORTIC STENOSIS AND INSUFFICIENCY; HOWEVER, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THEREFORE, WITHOUT EVALUATION OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE FAILURE TYPE LEADING TO THE REPORTED STENOSIS AND REGURGITATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, AND NO ADDITIONAL INFORMATION REGARDING THE REASON FOR EXPLANT AND PATIENT MEDICAL HISTORY WAS RELEASED. FOLLOW UPS ARE ONGOING AND UPDATES WILL BE PROVIDED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EDWARDS SALES THAT A MODEL 2800 29MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 12 YEARS. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    RECORDS INDICATE THE PATIENT WAS DIAGNOSED WITH AORTIC STENOSIS/INSUFFICIENCY (12 YEAR IMPLANT DURATION) AND 5.6 CM ASCENDING AORTIC ANEURYSM (AAA), AND THEREFORE UNDERWENT A REDO AVR AND AAA REPAIR. PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800 7L1246

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R