BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 2070673 · Received April 27, 2011

    Report

    Report Number
    2015691-2011-15344
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S04
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED EVENT PROBLEM. DEVICE (B)(4) - NO CODE AVAILABLE : INFECTED. ADDITIONAL MANUFACTURER NARRATIVE: COMPLAINT DATABASE INDICATES NO OTHER REPORTED EVENTS RELATED TO STERILIZATION, ENDOCARDITIS, OR SUSPECTED INFECTION ON ANY DEVICES MANUFACTURED WITHIN THE SAME STERILIZATION LOT OF THE PROVIDED SERIAL NUMBER. EDWARDS LIFESCIENCES MAINTAINS STERILIZATION CONTROLS AND VALIDATION STUDIES WHICH ARE CONDUCTED IN ACCORDANCE WITH ISO STANDARDS AND MEET GLOBAL REGULATIONS ASSURING DEVICE SAFETY. THESE VALIDATION STUDIES DEMONSTRATE HIGH EFFECTIVITY AND RELIABILITY, EXCEEDING STERILIZATION REQUIREMENTS. EDWARDS WAS NOTIFIED THAT THE SUBJECT VALVE COULD NOT BE RETURNED WITHOUT PATIENT AUTHORIZATION. OVERALL, BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: (B)(4) - NO INFORMATION BECAUSE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. EVALUATION: METHOD: (B)(4) - DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW HAS BEEN PERFORMED 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, AND EXCEEDS SPECIFICATIONS AND STANDARDS. BASED ON THE INFORMATION AVAILABLE, A CONCLUSIVE ROOT CAUSE TO THE ALLEGED ENDOCARDITIS IN NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS VALVE WAS EXPLANTED DUE TO ENDOCARDITIS AFTER 4 MONTHS IMPLANT DURATION. THE OPERATIVE REPORT STATES, "THE PATIENT WAS HAVING RECURRENT FEVERS STARTING IN (B)(6) 2011 AND WAS FOUND TO HAVE PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH A LARGE VEGETATION ON THE VENTRICULAR SIDE OF THE BIOPROSTHETIC, AS WELL AS AORTIC ROOT ABSCESS, SECONDARY TO (B)(4)." THE PATHOLOGY REPORT NOTED FOCAL AREAS OF TAN-PINK ADHERENT SOFT TISSUE FRAGMENTS ON THE VALVE LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10H2148

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R