BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 9130491 · Received September 27, 2019

    Report

    Report Number
    2015691-2019-03612
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 4, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: F10, 3191 = RESTRICTED LEAFLETS AND 3191 = ECHOGENIC MASS. THE DEVICE WAS NOT RETRIEVED DUE TO ENDOCARDITIS. PROSTHETIC ENDOCARDITIS WITH OR WITHOUT VEGETATION, OF VALVES AND ANNULOPLASTY RINGS IS A SERIOUS COMPLICATION OF VALVE REPLACEMENT AND VALVE REPAIR SURGERIES DESPITE IMPROVEMENTS IN PROSTHESES TYPES, SURGICAL TECHNIQUES, AND INFECTION CONTROL MEASURES. THIS INFECTION IS GENERALLY CATEGORIZED INTO EARLY (ONSET USUALLY LESS THAN 60 DAYS POSTOPERATIVE) AND LATE (ONSET GREATER THAN 60 DAYS POST-IMPLANTATION). LATE PROSTHETIC ENDOCARDITIS RESEMBLES NATIVE VALVE ENDOCARDITIS IN TERMS OF ETIOLOGICAL MICROBES, AND SOURCES OF CONTAMINATION ARE PRESUMABLY SIMILAR. LATE ENDOCARDITIS OCCURS DUE TO THE IMPLANT BEING SEEDED FROM AN INFECTION OR MICROBIAL CONTAMINATION FROM ELSEWHERE IN THE BODY. DENTAL, GENITOURINARY, AND GASTROINTESTINAL MANIPULATION ARE KNOWN CAUSES OF TRANSIENT BACTEREMIA, WHICH CAN PLACE A PATIENT AT RISK FOR PROSTHETIC ENDOCARDITIS. ADDITIONAL PROCEDURES PLACING PATIENTS AT RISK FOR PROSTHETIC ENDOCARDITIS INCLUDE URETHRAL CATHETERIZATION, COLONOSCOPY, BARIUM ENEMAS, AND SURGICAL PROCEDURES. BASED ON THE INFORMATION RECEIVED PATIENT FACTORS LIKELY CONTRIBUTED TO THE EVENT. HOWEVER, EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THROUGH FOLLOW UP EDWARDS RECEIVED INFORMATION A 27MM MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO MONTHS, 19 DAYS, DUE TO RECURRENT ENDOCARDITIS, THICKENED LEAFLETS, VEGETATION, AND STENOSIS. PATIENT HAD PROSTHETIC MITRAL VALVE ENDOCARDITIS DUE TO KLEBSIELLA PNEUMONIA. PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT WAS FOUND TO HAVE GNR BACTEREMIA AND LARGE VEGETATION ON MITRAL VALVE. MITRAL VALVE WAS REPORTED TO HAVE BEEN GROSSLY INFECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE DEVICE AND ADDITIONAL INFORMATION ARE IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION AND/OR ENDOCARDITIS. WITHOUT ADDITIONAL INFORMATION OR RECEIPT OF THE DEVICE THE CAUSE CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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, EDWARDS IMPLANT PATIENT REGISTRY RECEIVED INFORMATION THAT 27 MM MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO MONTHS, 19 DAYS, DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICES WAS REPLACED WITH A 29 MM MITRAL VALVE. PATIENT POST OPERATIVE STATUS NOTED AS IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925737 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX27

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R