BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2060258 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15239
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD (B)(4) X-RAY. EVALUATION SUMMARY: AS RECEIVED, THE EDWARDS VALVE EXHIBITS CUTS IN THE SEWING FABRIC. THE CUTS EXPOSED THE SEWING RING BY APPROXIMATELY 2CM; THE DISRUPTIONS ARE MOST LIKELY DUE TO USER HANDLING DURING IMPLANT OR EXPLANT. ALSO NOTICED THAT THE CENTRAL VALVE OPENING IS ASYMMETRICAL. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE INVESTIGATION REVEALS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT. EVALUATION INDICATES THAT THE REASON FOR EXPLANT IS LIKELY DUE TO USER HANDLING AND PATIENT ANATOMY.

    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, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS REMOVED DUE TO DIFFICULTY IN SEATING THE VALVE. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT PRESENTED WITH SEVERE AORTIC VALVE STENOSIS AND THEREFORE, WAS REFERRED FOR AORTIC VALVE REPLACEMENT. THE PATIENT HAD SEVERE DEGENERATIVE DISEASE OF ALL 3 LEAFLETS WITH FIBROSIS AND CALCIFICATION EXTENDING INTO THE NATIVE ANNULUS WITH SIGNIFICANT MOUNDS OF CALCIFICATION EXTENDING DOWN ONTO THE ANTERIOR LEAFLET OF THE MITRAL VALVE WHICH REQUIRED SIGNIFICANT DEBRIDEMENT. THE EDWARDS VALVE WAS ATTEMPTED TO BE IMPLANTED, BUT THERE WAS DIFFICULTY IN SEATING THE VALVE. WITH MANIPULATION, TRYING TO SEAT THE VALVE, THE FABRIC OF THE ANNULUS BEGAN TO FRAY SIGNIFICANTLY. IT WAS FELT THAT IT WAS NOT SAFE TO LEAVE THIS VALVE IN THE PATIENT. THEREFORE, THE VALVE WAS REMOVED AND ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. POST-VALVE INSERTION TEE REVEALED A WELL SEATED AND FUNCTIONING BIOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 R-10H2307

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention