BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2252070 · Received September 16, 2011

    Report

    Report Number
    2015691-2011-16181
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO RELATED ABNORMALITIES. DESPITE MULTIPLE ATTEMPTS, THE HOSPITAL DECLINED TO RETURN THE SUBJECT DEVICE TO EDWARDS FOR EVALUATION. ATTEMPTS TO OBTAIN PHOTOS OF THE EXPLANTED VALVE ARE ONGOING. EDWARDS INVESTIGATION AND CONCLUSIONS REGARDING THIS EVENT WILL BE REPORTED ONCE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 91 MONTHS. PATIENT UNDERWENT RE-ENTRY AORTIC ROOT REPLACEMENT WITH ANOTHER 29MM EDWARDS MAGNA BOVINE PERICARDIAL VALVE WITHIN A 32MM GELWEAVE VALSALVA GRAFT (BIOLOGICAL BENTALL REPAIR), AND AN AORTIC HEMI-ARCH REPAIR. THE EXPLANTING SURGEON INDICATES, "THE STRUT AT THE LEFT/RIGHT COMMISURE WAS FRACTURED AND HE DID HAVE AT LEAST MOD AI WITH AN ODD ECCENTRIC JET. HIS SURGERY WAS PREDICATED ON HIS ASCENDING AORTA WHICH WAS ANEURYSMAL. THE PROSTHESIS ITSELF DID NOT DETERMINE HIS SURGERY. THAT SAID, THERE WAS LITTLE CHOICE BUT TO EXPLANT IT. THE INJURY IS VISIBLE ON THE PATIENTS CATH FILM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 3A0177

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R