BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3103428 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20046
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH) AND INSUFFICIENCY (E.G. LEAFLET DISRUPTION). UNFORTUNATELY, THE VALVE WAS NOT EXPLANTED FROM THE PATIENT; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION RECEIVED, ¿THE TRANSAPICAL PROCEDURE WAS DONE WITHIN GOOD RESULTS BUT THE PATIENT ACQUIRED AND AV BLOCK POST PROCEDURE REQUIRING A DUAL CHAMBER PACEMAKER IMPLANT. THE PATIENT RECOVERED WELL AND WAS DISCHARGED HOME ON DAY 6 IN GOOD CONDITION.¿ PERI-PROCEDURAL ARRHYTHMIAS, HEART BLOCK, AND OTHER CONDUCTION DISTURBANCES ARE COMMON IN PATIENTS WITH UNDERLYING CARDIOVASCULAR DISEASE AND/OR CONDUCTION ABNORMALITIES. THEY CAN BE EXACERBATED WITH STANDARD PERI-OPERATIVE MEDICATIONS, ANESTHESIA, AND/OR INSTRUMENTATION OF THE HEART. TEMPORARY PACEMAKERS ARE INSERTED IN ALL PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT (AVR). IT IS NOT UNCOMMON FOR PATIENTS TO HAVE SHORT TERM/REVERSIBLE PERIODS OF HEART BLOCK OR ARRHYTHMIAS FOLLOWING THE PROCEDURE WHILE THEIR HEART RECOVERS FROM CARDIOPULMONARY BYPASS. IN MANY CASES, THE TEMPORARY PM IS LEFT IN THE PATIENT FOR A SHORT TIME FOLLOWING THE PROCEDURE AND THEN SUBSEQUENTLY REMOVED PRIOR TO DISCHARGE. IN THIS CASE, THE PATIENT EXPERIENCED AV HEART BLOCK POST PROCEDURE REQUIRING PERMANENT PACEMAKER, THE PATIENT RECOVERED WELL AND WAS DISCHARGE HOME ON DAY 6 IN GOOD CONDITION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND 4 MONTHS. THE CARDIOLOGIST INDICATED THE REASON FOR THIS PROCEDURE WAS DUE TO "EVIDENCE OF AT LEAST MODERATE AORTIC INSUFFICIENCY WITH SEVERE BIOPROSTHETIC AORTIC VALVE STENOSIS." IT WAS FURTHER REPORTED BY THE CLINICAL SPECIALIST THAT THE PATIENT DID VERY WELL POST-OP AND WAS DISCHARGED ON DAY 5. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204017 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R