BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2103254 · Received May 25, 2011

    Report

    Report Number
    2015691-2011-15618
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: (B)(4) 2011, REQUESTED COPY OF ECHO ON CD ALONG WITH PATIENT MEDICAL HISTORY, OPERATIVE REPORT, EXPLANT DATE AND S/N OF DEVICE. A 2ND DEVICE, IMPLANTED IN THE TRICUSPID POSITION WAS ALSO EXPLANTED SAME DATE. REQUESTED CONFIRMATION OF POSSIBLE INFECTION TO EXPLAIN EARLY EXPLANT, PRIOR HISTORY OF CALCIFICATION, ETC. DHR CANNOT BE DONE UNTIL THE SERIAL NUMBER IS KNOWN. REQUESTING PERMISSION TO DISMANTLE THE DEVICE FOR S/N POST EVAL.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED: (B)(6) 2011 THROMBUS LIKE DEPOSITS ARE EVIDENT AT THE TISSUE INFLOW. ALL THREE LEAFLETS EXHIBIT A DROP WHICH LED TO INCOMPLETE COAPTATION; REASON IS INDETERMINABLE. MINIMAL THIN LAYER OF HOST TISSUE OVERGROWTH IS DETECTED AT THE TISSUE OUTFLOW. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT INFLOW AND STENT OUTFLOW. CUT OUTS IN THE SEWING RING, MOST LIKELY DUE TO EXPLANT EXPOSED THE WIREFORM. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. ADDITIONAL MANUFACTURER NARRATIVE: (B)(6) 2011 THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE SURGEON'S REPORT INDICATED THAT NO ADDITIONAL INFORMATION WOULD BE PROVIDED. WITHOUT ADDITIONAL INFORMATION REGARDING THE PATIENT HISTORY, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE. METHOD: (B)(4) X-RAY DATE USER FACILITY BECAME AWARE OF EVENT WERE UPDATED BASED ON THE SURGEON'S RESPONSE.

    Description of Event or Problem · 1

    REPORTEDLY, A MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 MONTHS DUE TO SEVERE MITRAL REGURGITATION DETECTED ON ECHO (B)(6) 2011. PATIENT HAD A 2ND DEVICE EXPLANTED AT THE SAME TIME FROM THE TRICUSPID POSITION FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 09L309

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R