BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2671745 · Received July 26, 2012

    Report

    Report Number
    2015691-2012-17967
    Event Type
    Injury
    Date Received
    July 26, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 29, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. 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 DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED. THE PATIENT'S SURGICAL NOTES ALSO DOCUMENT A HISTORY OF ENDOCARDITIS. 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, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PROSTHETIC MITRAL VALVE ENDOCARDITIS (MVE). PER THE PATIENT'S SURGERY NOTES, SHE WAS FIRST DIAGNOSED WITH MVE (B)(6) 2012 AND RECEIVED A COURSE OF ANTIBIOTICS FOLLOWED BY MITRAL VALVE REPLACEMENT (MVR) IN (B)(6) 2012 WITH THE SUBJECT DEVICE. HER POSTOPERATIVE COURSE WAS COMPLICATED BY THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) AND HYDROCEPHALUS S/P CRANIECTOMY. SHE RECOVERED FROM THIS AND WAS TRANSFERRED TO REHAB. SHE WAS READMITTED (B)(6) 2012 WITH SEPSIS, RESPIRATORY FAILURE REQUIRING INTUBATION, CARDIOGENIC SHOCK, AND ACUTE KIDNEY INJURY. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED REPEAT MVE AS WELL AS AORTIC VALVE VEGETATIONS AND INVOLVEMENT. THE PATIENT WAS TRANSFERRED FOR REDO MVR WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. TEE ON (B)(6) 2012 SHOWED A MEAN TRANSMITRAL GRADIENT OF 4.7 MMHG AT THE HEART RATE OF 92 BPM. IT WAS ALSO NOTED THAT ONE LEAFLET APPEARED THICKENED. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-10D0909

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R