BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2945950 · Received February 6, 2013

    Report

    Report Number
    2015691-2013-19207
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    May 28, 2012
    Report Date
    January 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. EXPLANTS AT IMPLANT ARE TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION AND WITHOUT THE SAMPLE DEVICE. HOWEVER, THE SURGEON HAS INDICATED THAT THIS EVENT WAS CAUSED BY AV DEHISCENCE. THERE IS NO INFORMATION SUGGESTING THAT THERE WAS A MALFUNCTION OR DEFICIENCY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL INFORMATION PROVIDED BY THE HEALTH-CARE PROVIDER, ONLY THE SUBJECT VALVE WAS REMOVED DUE TO AORTIC ROOT REPLACEMENT; THE MITRAL VALVE REMAINS IMPLANTED. BASED ON THE INFORMATION PROVIDED, THE EXPLANT OF THE SUBJECT DEVICE WAS DUE TO PROPHYLACTIC REPLACEMENT AND NOT RELATED TO ANY DEVICE MALFUNCTION OR QUALITY DEFICIENCY. ON OCCASION VALVES MAY BE EXPLANTED WITH NO EVIDENCE OF MALFUNCTION AND ARE OTHERWISE PERFORMING AS INTENDED. FOR EXAMPLE, A PATIENT MAY UNDERGO OPEN-HEART SURGERY FOR AN UNRELATED REASON. IF AN INDWELLING VALVE HAS BEEN PRESENT FOR MANY YEARS, THE SURGEON MAY ELECT TO REPLACE IT DURING AN UNRELATED CARDIAC SURGERY. IN ADDITION, THERE MAY BE CASES IN WHICH THERE IS INTRA OR POST-OPERATIVE BLEEDING RELATED TO THE PROCEDURE AND NOT DIRECTLY RELATED TO THE VALVE. IN THESE CASES, THE VALVE MAY REQUIRE REMOVAL TO FACILITATE REPAIR OF THE INJURY. THERE IS NO INFORMATION SUGGESTING THAT THERE WAS A MALFUNCTION OR DEFICIENCY OF THE DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 VALVE WAS IMPLANTED AND THEN EXPLANTED DURING THE SAME SURGERY. PER THE SURGEON'S RESPONSE RECEIVED ON (B)(6) /2013, AFTER HER AORTIC VALVE REPLACEMENT, THE PATIENT HAD A PROBLEM WITH HER AORTIC ROOT WITH BLEEDING. THE DEVICE WAS THEN REMOVED AND THE SURGEON DID AN AORTIC ROOT REPLACEMENT WITH A COMPOSITE BIOVALSALVA GRAFT AND ALSO REPLACED THE MITRAL VALVE. THE PATIENT WAS DISCHARGED HOME SAFELY ON POD #8 AND WAS WELL AT FOLLOW UP. THE ISSUE WAS DETECTED WHEN THE PATIENT HAD ALREADY BEEN TAKEN OFF BYPASS AND PROTAMINE ADMINISTERED. THE SURGEON ALSO INDICATED THE CAUSE OF THE BLEEDING TO BE AV DEHISCENCE. NO OTHER DETAILS WERE PROVIDED. MOREOVER, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51149 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention