BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1984399 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14782
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    April 20, 2009
    Report Date
    January 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED DUE TO INFECTION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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. IN THIS CASE, THE SOURCE AND TYPE OF THE BACTERIAL ENDOCARDITIS HAVE NOT BEEN PROVIDED; THEREFORE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE ENDOCARDITIS.

    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, THE DEVICE WAS EXPLANTED AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS DUE TO ENDOCARDITIS. PER THE TRANSLATED OPERATIVE REPORT: MEDICAL HISTORY: PATIENT HAD ALREADY UNDERGONE HEART SURGERY IN THE PAST. HE ARRIVED AT THE INFECTIOUS DISEASES WARD DUE TO A BACTERIAL ENDOCARDITIS ON THE PROSTHETIC VALVE. ON (B)(6) 2009, HE TRANSFERRED INTO OUR WARD TO UNDERGO HEART SURGERY. SURGERY: THE BIOPROSTHESIS PREVIOUSLY IMPLANTED APPEARS AFFECTED BY THE ENDOCARDITIC PROCESS WHICH INVOLVES THE POSTERIOR ANNULUS AND ALL THE LEAFLETS, ESPECIALLY THE ANTEROLATERAL WHERE THERE IS PRESENT PEDUNCULATED VEGETATION ON THE ATRIAL SIDE. THE BIOPROSTHESIS WAS EXPLANTED AND REPLACED BY A NEW [EDWARDS CE31MM] BIOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 07J224

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R AMPITAL 3GR X 4| TRIATEC 5MG 1 TABLET X 2| LASIX 25MG 1 TABLET| COUMADIN S.S| ANTRA 1 TABLET X 2| GENTALYN| ALDAETONE 100MG 1 TABLET