BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2931053 · Received January 28, 2013

    Report

    Report Number
    2015691-2013-19163
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO FOLLOW UP DOCTOR OR EXPLANT SURGEON INFORMATION HAS BEEN PROVIDED. NO PATIENT HEALTH INFORMATION OR PATIENT STATUS HAS BEEN PROVIDED. IT IS UNKNOWN IF ANY INFORMATION WILL BE MADE AVAILABLE. THE 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED BY A 19MM VALVE. THE REASON FOR EXPLANT OF THIS DEVICE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THE DEVICE WAS EXPLANTED DUE TO REGURGITATION AND ENDOCARDITIS. THE DEVICE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE HOSPITAL DUE TO INFECTION. 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 INFECTION HAVE NOT BEEN DISCLOSED. WITHOUT INFORMATION REGARDING SOURCE AND TYPE OF INFECTION OR RETURN OF THE DEVICE, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR EXPLANT OF THIS DEVICE. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR EVENT IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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, A 21MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4.73 MONTHS DUE TO UNKNOWN REASONS. THE AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A MAGNA EASE VALVE, MODEL 3300TFX19MM. NO FURTHER DETAILS WERE PROVIDED. INFORMATION WAS LEARNED THROUGH OUR (B)(6) IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36436 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX 12E162

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R