BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2151786 · Received July 6, 2011

    Report

    Report Number
    2015691-2011-15833
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS' AORTIC BIOPROSTHESIS WAS EXPLANTED AT IMPLANT, AND REPLACED WITH A SAME MODEL, SMALLER SIZE VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO A PERIVALVULAR LEAK NOTICED AFTER COMING OFF BYPASS. OPERATIVE REPORT INDICATES, "WE MADE A TRANSVERSE AORTOTOMY ABOVE ALL OF THE CALCIUM. THIS MADE EXPOSURE OF THE AORTIC VALVE SOMEWHAT DIFFICULT BUT WE ARE ABLE TO DEBRIDE THE [NATIVE] AORTIC VALVE OF ITS CALCIUM AND DEBRIDE THE CALCIUM OFF THE ANNULUS. THERE WAS A FAIR AMOUNT OF CALCIUM IN THE ASCENDING AORTA AS WELL AS IN THE ANNULUS. WE THEREFORE SIZED IT FOR A 25-MM VALVE. THE VALVE WAS SEATED, SUTURED, TIED, AND CUT. BOTH CORONARY OSTIA WERE FREE. WE REMOVED THE CROSSCLAMP AND WENT OFF BYPASS. THERE WAS A SMALL PERIVALVULAR LEAK BETWEEN THE LEFT AND RIGHT COMMISSURES. THIS WAS LIKELY DUE TO SOME CALCIUM IN THE AORTA AND ANNULUS. WE THEREFORE, WENT ON BYPASS AND RECLAMPED, AND OPENED UP THE AORTA AND DISCOVERED THAT THIS WAS AN UNSATISFACTORY SITUATION. THEREFORE, WE REMOVED THE 25-MM VALVE AND PLACED A 23-MM VALVE USING SAME TECHNIQUE OF INTERRUPTED ETHIBOND MATTRESS SUTURES". THERE HAS BEEN NO INFORMATION REPORTED TO SUGGEST A DEVICE MALFUNCTION RELATED TO THIS EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700TFX R-11A0272

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R