BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 2418429 · Received January 17, 2012

    Report

    Report Number
    1063481-2012-00003
    Event Type
    Death
    Date Received
    January 17, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 17, 2012
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, AN RV-PA CONDUIT PLACEMENT PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. APPROXIMATELY ONE HOUR AFTER SURGERY THE PATIENT DISPLAYED SIGNS OF CARDIAC TAMPONADE. THE PATIENT WAS RETURNED TO SURGERY FOR CONTROL OF SUSPECTED BLEEDING. CPR WAS IN PROGRESS. THERE WAS A TEAR FOUND IN THE GRAFT. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND THE SITE WAS REPAIRED WITH PATCH MATERIAL. HOWEVER, THE PATIENT DID NOT RECOVER. THE TEAR WAS NOTED IN THE PROXIMAL MUSCULAR PORTION OF CONDUIT. THE HOSPITAL ALSO INDICATED THAT THE GRAFT APPEARANCE AND TEXTURE WERE THE SAME AS USUAL, OTHER THAN, A SLIGHT YELLOW COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY VALVE & CONDUIT SG HUMAN HEART ALLOGRAFT MIE CRYOLIFE, INC. SGPV00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death