BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4260498 · Received November 19, 2014

    Report

    Report Number
    2015691-2014-02729
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: # DEVICE NOT RETURNED. THIS DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT WAS DISCARDED BY THE HOSPITAL. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROGRESS. THE HEALTH CARE PROVIDER INDICATED THIS VALVE WAS EXPLANTED AFTER IMPLANT DUE TO A PARAVALVULAR LEAK. A PARAVALVULAR LEAK IS DESCRIBED AS A LEAK OUTSIDE THE VALVE, NOT GOING THROUGH THE LEAFLETS, AND REPRESENTS REGURGITANT FLOW BETWEEN THE SEWING RING AND THE AORTIC WALL. IF HEMODYNAMICALLY SIGNIFICANT, THIS WILL REQUIRE REPLACEMENT OF THE HEART VALVE. THERE ARE SEVERAL CONTRIBUTING FACTORS TO A PARAVALVULAR LEAK, INCLUDING BUT NOT LIMITED TO, INSUFFICIENT DEBRIDEMENT OF CALCIFIED TISSUE, SURGICAL TECHNIQUE, AND PATIENT FACTORS (FRAGILE TISSUE). IN THIS CASE, THE PATIENT'S BICUSPID NATIVE AORTIC VALVE MAY HAVE CONTRIBUTED TO THE PARAVALVULAR LEAK. THERE WAS NO INDICATION OF A MALFUNCTION OR DEFICIENCY OF THE BIOPROSTHETIC AORTIC HEART VALVE. SEE ALSO REPORT FOR S/N (B)(4).

    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 25MM AORTIC VALVE WAS EXPLANTED AT IMPLANT AND REPLACED WITH ANOTHER 25MM AORTIC PERICARDIAL VALVE (SAME MODEL AND SIZE). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THE INITIAL DEVICE WAS EXPLANTED AFTER IMPLANT DUE TO A PVL. THE SECOND 25MM AORTIC ALSO SHOWED PVL AFTER IMPLANT BUT WAS CORRECTED AFTER GOING BACK ON BYPASS. THE OPERATIVE REPORT PROVIDED THE FOLLOWING INFORMATION: AFTER IMPLANT OF THE 1ST 25MM AORTIC VALVE: RETROPLEGIC CATHETER WAS REMOVED AND, UPON COMPLETE REWARMING AND ADEQUATE DE-AIRING MANEUVERS, PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS ON LOW-DOSE INOTROPIC SUPPORT. HE MAINTAINED STABLE HEMODYNAMICS AND WAS DECANNULATED. HEPARIN WAS REVERSED WITH PROTAMINE. AT THIS TIME, WE NOTED THAT THERE WAS A VERY HIGH-VELOCITY JET INDICATING A PVL LEAK AND, AFTER MUCH DISCUSSION... WE DECIDED THAT WE WOULD REPLACE THIS VALVE AGAIN IN VIEW OF THIS PVL. THERE WAS NO VALVULAR ROCKING; HOWEVER, THIS WAS A VERY HIGH-VELOCITY JET INDICATING A PVL. [PT WAS PLACED BACK ON CPB] ON REINSPECTION OF THE VALVE, THE VALVE APPEARED COMPLETELY INTACT, BUT I COULD NOT ASCERTAIN WHERE THE PVL WAS OCCURRING. THEREFORE, I EXPLANTED THE VALVE... ON RESIZING, WE DECIDED TO USE A 25 EDWARDS PROSTHESES. SEE ALSO REPORT FOR S/N (B)(4) . AFTER IMPLANT OF THE SECOND DEVICE, PATIENT WAS SUCCESSFULLY WEANED FROM CPB. ON RE-INTERROGATION OF THE VALVE, THERE WAS NO AORTIC INSUFFICIENCY OR PVL NOTED. PATIENT WAS TRANSPORTED TO THE CTICU IN STABLE, BUT CRITICAL CONDITION ON LOW-DOSE INOTROPIC SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748893 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R