BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2073472 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15400
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AORTIC VALVE INFECTIOUS ENDOCARDITIS. EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE FOLLOW-UP WITH THE HEALTHCARE PROVIDER, THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE INVESTIGATION REVEALS NOTHING TO INDICATE A QUALITY DEFICIENCY WITH THE EDWARDS VALVE.

    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, IT WAS REPORTED THAT THE EDWARDS' VALVE WAS EXPLANTED 3 MONTHS AFTER IMPLANT DUE TO ENDOCARDITIS, AND THE PATIENT DIED DURING SURGERY. MEDICAL RECORDS INDICATE, " PATIENT WAS DIAGNOSED WITH PROTHETIC AORTIC VALVE ENDOCARDITIS WITH SEPTIC EMBOLI AS CONFIRMED BY THE TEE, POSITIVE BLOOD CULTURES, AND MRI OF THE HEAD. IN ADDITION HE UNDERWENT A THROMBECTOMY OF HIS LEFT UPPER EXTREMITY ARTERIAL SYSTEM WITH REMOVAL OF SEPTIC THROMBUS, ALSO POSITIVE FOR A COAGULASE-NEGATIVE STAPHYLOCOCCUS." OPERATIVE REPORT INDICATES, " PATIENT WAS TO UNDERGO REOPERATIVE AORTIC VALVE REPLACEMENT. HOWEVER, HE SUFFERED A CARDIAC ARREST X2 PRIOR TO THE OPERATION. HE UNDERWENT CARDIOPULMONARY RESUSCITATION VIA CHEST COMPRESSIONS AND EVENTUALLY UNDERWENT EMERGENT REOPERATIVE STERNOTOMY AND FEMORAL-FEMORAL BYPASS." "TEE REVEALED A MASSIVE AMOUNT OF INTRACARDIAC THROMBUS INVOLVING HIS LEFT HEART AND THEREFORE HE UNDERWENT REMOVAL OF THAT THROMBUS UNDER PROFOUND HYPOTHERMIA AND CIRCULATORY ARREST. HE UNDERWENT AORTIC VALVE GRAFT CONDUIT WITH REIMPLANTATION OF THE CORONARY ARTERIES FOR THIS. HOWEVER, THE PREOPERATIVE CARDIAC ARREST MAY HAVE BEEN TOO SIGNIFICANT AN INSULT ON HIS SYSTEMS SUCH THAT THE PATIENT WAS NOTABLE TO BE WEANED SUCCESSFULLY OFF CARDIOPULMONARY BYPASS."

    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-10A0152

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R