BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4140288 · Received October 3, 2014

    Report

    Report Number
    2015691-2014-02314
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. THE RETURNED VALVE WAS WITHIN SPECIFICATIONS FOR LABELED SIZING. NO FURTHER INVESTIGATION WILL BE PERFORMED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONHTLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER REPORT OF SIZING ISSUE WAS NOT CONFIRMED. EXTERNAL SEWING RING DIAMETER OF VALVE AND STENT DIAMETER WERE MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATIONS PER IFU. NO APPARENT INCONSISTENCIES WERE OBSERVED ON THE VALVE. VALVE WAS DISMANTLED TO CONFIRM SIZE AND SERIAL NUMBER. THE X-RAY DEMONSTRATED NO VISIBLE DAMAGE TO WIREFORM. RESULTS: ACTUAL DEVICE MEASURED ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL EVALUATION WILL BE CONDUCTED BY ENGINEERING AND A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THIS INVESTIGATION. NO ADDITIONAL INFORMATION IS KNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL. WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. HOWEVER, AV GROOVE DISRUPTION IS TYPICALLY NOT DEVICE RELATED. AV DISSOCIATION IS USUALLY RELATED TO VIGOROUS TRACTION OR DEBRIDEMENT OF THE POSTERIOR LEAFLET OF THE VALVE OR TO CALCIUM EXCISION IN A CALCIFIED POSTERIOR LEAFLET. THIS CAN CAUSE SEPARATION OF THE AV GROOVE, LEADING TO HEMORRHAGE UPON SEPARATION FROM CARDIOPULMONARY BYPASS. WHEN THIS COMPLICATION OCCURS, VALVE PROSTHESIS IS REMOVED AND THE VENTRICLE IS REAPPROXIMATED TO THE LEFT ATRIUM WITH FELT STRIPS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE IFU HAS BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 33MM MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO SIZING ISSUE COMPLICATED BY ATRIOVENTRICULAR DISRUPTION. OPERATIVE NOTE INDICATED THAT APPROXIMATELY 25 TO 30 MINUTES AFTER CLOSURE, THE PHYSICIAN WAS CALLED "BECAUSE THE PATIENT APPROXIMATELY PUT OUT 150ML ALMOST IMMEDIATELY. THE MEDIASTINUM WAS REOPENED, EXPLORATION WAS UNDERTAKEN. INSPECTION FOUND COPIOUS BLEEDING FROM THE CIRCUMFLEX DISTRIBUTION OF THE POSTERIOR ASPECT OF THE VALVE. PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM MITRAL VALVE. THE PATIENT WAS TRANSFERRED TO THE ICU IN CRITICAL CONDITION. IT WAS LATER LEARNED THAT THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE WHICH WAS UNRELATED TO THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619013 CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX33

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R