BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3013628 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19603
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IN THIS CASE, THE DISCHARGE SUMMARY DOCUMENTS THAT THIS PATIENT HAD LUMBAR LAMINECTOMY FOR ONGOING BACK ISSUES AND SUBSEQUENTLY DEVELOPED STAPH EPI. LUMBAR ABSCESS. THIS WAS LIKELY THE SOURCE OF THE PATIENT'S INFECTION. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT THE SAMPLE DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS WITH VEGETATIONS. ACCORDING TO THE DISCHARGE SUMMARY, THIS PATIENT HAD THIS PROSTHETIC AORTIC VALVE IMPLANTED IN (B)(6) 2012. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY CARDIAC TAMPONADE WHILE ON HEPARIN. ONCE DISCHARGED HE OPTED FOR LUMBAR LAMINECTOMY FOR ONGOING BACK ISSUES AND SUBSEQUENTLY DEVELOPED STAPH EPI. LUMBAR ABSCESS. TEE SHOWED LARGE VEGETATION ON THE PROSTHETIC AORTIC VALVE WITH REGURGITATION. HE WAS EVALUATED BY NEUROSURGERY AND INFECTIOUS DISEASE SERVICE IN ANTICIPATION OF REDO-AORTIC VALVE REPLACEMENT. PER THE OPERATIVE FINDINGS, THERE WERE VEGETATIONS OF 2 OF 3 OF THE PROSTHETIC VALVE LEAFLETS. THERE WAS FRIABLE PERIANNULAR TISSUE WITHOUT EVIDENCE OF ABSCESS. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. TEE SHOWED EXCELLENT SEATING AND FUNCTION OF THE NEW PROSTHETIC VALVE. THE PATIENT WAS NOTED TO HAVE A REMARKABLY WELL POSTOPERATIVE COURSE AND WAS DISCHARGED TO AN INPATIENT REHAB FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116346 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-12D1311

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R