BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1983004 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14764
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 12, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE OPERATIVE REPORT AND DISCHARGE SUMMARY HAVE BEEN REQUESTED BUT HAVE NOT BEEN PROVIDED. EXPLANT DATE REMAINS UNKNOWN. ADDITIONAL PATIENT INFORMATION IS UNAVAILABLE. TYPE OF INFECTION WAS CONFIRMED BY HOSPITAL RISK MANAGEMENT AS STAPH EPIDERMIDIS. DEVICE RETURN FOR EVALUATION IS PENDING. DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: EDWARDS LIFESCIENCES RECEIVED AN FDA REQUEST FOR ADDITIONAL INFORMATION ON THIS REPORT, DATED (B)(4) 2011. ATTACHED TO THIS REPORT, PLEASE FIND A DETAILED RESPONSE TO THE REQUESTED ADDITIONAL INFORMATION, IN ADDITION TO FINDINGS FROM THE RECEIVED OPERATIVE REPORT. EDWARDS 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. OVERALL, THE INVESTIGATION REVEALS NOTHING TO INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF EDWARDS' DEVICE, THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    REPORTEDLY, THE SALES REPRESENTATIVE RECEIVED AN EMAIL ON (B)(6) 2011 FROM THE HOSPITAL THAT A DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 MONTHS DUE TO AN UNEXPLAINABLE INFECTION. THE HOSPITAL HAS CONFIRMED THAT THE REASON FOR EXPLANT WAS ENDOCARDITIS AND THE VEGETATION ON THE VALVE TESTED FOR GRAM-NEGATIVE STAPH EPIDERMIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-10G1766

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R