BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2890258 · Received December 29, 2012

    Report

    Report Number
    2015691-2012-18970
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN AND EVALUATION.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO A SIZING ISSUE. THE OP REPORT DOCUMENTS THE 31 MM PROSTHETIC VALVE BEING IMPLANTED IN THE MITRAL POSITION UNEVENTFULLY. FOLLOWING SEPARATION FROM CARDIOPULMONARY BYPASS (CPB), MASSIVE BLEEDING WAS FOUND IN THE PERICARDIAL WELL WITH NO EVIDENCE OF THE SOURCE OF BLEEDING. CONSEQUENTLY GIVEN THESE CIRCUMSTANCES, A DECISION WAS MADE TO RE-EXPLORE THE HEART. THIS REVEALED AN EXTENSIVE HEMATOMA OVER THE APEX OF THE HEART THAT WAS EXTENDING INTO THE AV GROOVE SUGGESTING THE POSSIBLE DEVELOPMENT OF ATRIOVENTRICULAR DISRUPTION. GIVEN THESE CIRCUMSTANCES, THE PATIENT'S HEART WAS RE-ARRESTED AND THE MITRAL VALVE WAS EXPLORED AGAIN. WITH THE 31 MM BIOPROSTHESIS REMOVED, THERE WAS NO OBVIOUS DISSOCIATION IDENTIFIED. THERE WAS SOME LACERATION OF THE POSTERIOR LEFT ATRIAL WALL WHICH WAS REPAIRED WITH SUTURES. IT WAS DECIDED TO IMPLANT A 29 MM NON-EDWARDS MECHANICAL VALVE THE SECOND TIME AROUND. ATTEMPTS WERE MADE TO WEAN THE PATIENT OFF CPB; HOWEVER, THERE WAS MASSIVE BLEEDING ENCOUNTERED FROM THE APEX AGAIN. ATTEMPTS WERE MADE TO REPAIR THIS WHICH WERE UNSUCCESSFUL. IT WAS DECIDED TO IMPLANT A LVAD DEVICE TO PROMOTE HEALING AT THE APEX. NO OTHER BLEEDING SITE WAS IDENTIFIED. THE PATIENT WAS ABLE TO BE WEANED FROM CPB. AT THIS POINT, THERE WAS A RIGHT VENTRICULAR RUPTURE AT THE APEX THAT ALSO COULD NOT BE CONTROLLED. IT WAS DECIDED TO IMPLANT A RVAD DEVICE AT THIS TIME. THE PATIENT WAS TRANSPORTED TO THE ICU WITH OPEN CHEST FOR FURTHER CARE. NO OTHER DETAILS PROVIDED. EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE SURGEON HAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE EDWARDS VALVE. IT WAS NOTED THAT THIS EVENT WAS DUE TO A SIZING ISSUE. UNFORTUNATELY, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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, A 31MM MITRAL VALVE WAS EXPLANTED AT IMPLANT. THE REASON FOR EXPLANT IS UNKNOWN. NO REPLACEMENT DEVICE INFORMATION PROVIDED. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R