BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 1871939 · Received October 16, 2010

    Report

    Report Number
    2015691-2010-14214
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    June 13, 2009
    Report Date
    September 21, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. CONCLUSION: THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. ACCORDING TO LITERATURE, IRREVERSIBLE AV BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION IS AN UNCOMMON CONDITION FOLLOWING AORTIC VALVE REPLACEMENT. THE INCIDENCE OF CONDUCTION DISORDERS REQUIRING PERMANENT PACING IN PATIENTS OPERATED ON FOR AORTIC VALVE REPLACEMENT HAS BEEN REPORTED TO BE 5.7%. HOWEVER, PERIOPERATIVE RISK PREDICTORS FOR PERMANENT PACEMAKER IMPLANTATION AFTER AORTIC VALVE REPLACEMENT ARE NOT WELL CHARACTERISED.

    Additional Manufacturer Narrative · 1

    (B)(4)=COMPLETE HEART BLOCK WHEN THE PACER IS OFF.DEVICE NOT RETURNED.THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLYIN PROCESS. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE PATIENT HAD AN AORTIC VALVE REPLACEMENT. ALTHOUGH SCHEDULED FOR CORONARY ARTERY BYPASS GRAFTING AT THE SAME TIME, IT WAS NOT PERFORMED DUE TO ADHESIONS FROM PREVIOUS BYPASS GRAFTING. THE CORONARY STENOSIS WAS SCHEDULED FOR REPAIR LATER VIA PLACEMENT OF A DRUG ELUTING STENT THOUGH PERCUTANEOUS INTERVENTION. THE PATIENT TOLERATED THE AORTIC VALVE REPLACEMENT WELL. ACCORDING TO THE OPERATIVE REPORT, "THE VALVE WAS SEATED AND THE INDIVIDUAL SUTURES LIGATED. WE CONFIRMED PROPER PLACEMENT AND SEATING OF THE VALVE AT THE END OF THE PROCEDURE. THE VALVE SHOWED NO EVIDENCE OF AORTIC INSUFFICIENCY OR PERIVALVULAR LEAK". THE PATIENT HAD INTERMITTENT 3RD DEGREE ATRIOVENTRICULAR BLOCK ON POST-OP DAY 2. WHEN THE PATIENT WAS FULLY PACED AT A RATE OF 100, THE PATIENT WAS NOTED TO HAVE COMPLETE HEART BLOCK WHEN THE PACER WAS OFF. THE PATIENT UNDERWENT ANOTHER SURGERY FOR DUAL-CHAMBER PACEMAKER PLACEMENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED THROUGH A POST MARKET CLINICAL STUDY: THE PATIENT HAD AN AORTIC VALVE IMPLANTED POST OP DAY #2, PATIENT WAS FULLY PACED AT A RATE OF 100, AND NOTED TO HAVE COMPLETE HEART BLOCK WHEN THE PACER WAS OFF. ACCORDING TO THE CASE REPORT FORM, THIS EVENT WAS NOT DUE TO A DEVICE MALFUNCTION. HOWEVER, THE HEALTHCARE PROVIDER INDICATED THAT THE RELATIONSHIP TO THE DEVICE AND PROCEDURE IS "POSSIBLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09C0501

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention