BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3802875 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01098
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE THE DEVICE REMAINS IMPLANTED AFTER A VALVE-IN-VALVE PROCEDURE. HOWEVER, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO RELATED NONCONFORMANCE. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. TYPICALLY, MILD REGURGITATION IS NOT UNUSUAL AFTER INITIAL VALVE REPLACEMENT, AND IS USUALLY TOLERATED BY PATIENTS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING REOPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM THE CLINICAL COMMENTS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, EDWARDS HAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 23MM AORTIC VALVE WAS REPLACED IN A VALVE-IN-VALVE PROCEDURE DUE TO SIGNIFICANT AORTIC INSUFFICIENCY. THE AORTIC DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 14 YEARS, 6 MONTHS, AT TIME OF REPLACEMENT. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, THE OPERATIVE REPORT, DISCHARGE SUMMARY AND PRE-OP ECHO RESULTS WERE PROVIDED. "THIS IS A (B)(6) WHITE MALE WITH PAST MEDICAL HISTORY SIGNIFICANT FOR PREVIOUS AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING X4 IN 1999 WITH SUBSEQUENT PERCUTANEOUS CORONARY INTERVENTIONS WITH MULTIPLE STENTS PLACED TO THE SAPHENOUS VEIN GRAFTS, WHO HAS DEVELOPED DETERIORATION OF HIS PROSTHETIC AORTIC VALVE AND HAS BEEN FOUND TO HAVE SEVERE AORTIC INSUFFICIENCY. DUE TO INCREASING SHORTNESS OF BREATH, HE WAS REFERRED ... FOR POSSIBLE TRANSCATHETER AORTIC VALVE REPLACEMENT." PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280681 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R