BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 3725540 · Received April 3, 2014

    Report

    Report Number
    2015691-2014-00774
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    February 8, 2014
    Report Date
    March 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/(B)(4). MULTIPLE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED AND THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS. AT THIS TIME, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    ON OCCASION, VALVES MAY BE EXPLANTED WITH NO EVIDENCE OF MALFUNCTION AND ARE OTHERWISE PERFORMING AS INTENDED. IN THIS CASE, THE VALVE WAS EXPLANTED AS THE PATIENT REQUIRED A BENTALL TO CORRECT A DISSECTING ANEURYSM.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED TWO (2) YEARS AND SIX (6) MONTHS, WAS EXPLANTED IN ORDER TO PERFORM A BENTALL SURGERY TO CORRECT DISSECTING ANEURYSM. THIS WAS REPLACED WITH A 23 MM EDWARDS BIOPROSTHESIS. NO ADDITIONAL DETAILS PROVIDED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED TWO (2) YEARS AND SIX (6) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200685 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R