BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2231456 · Received September 1, 2011

    Report

    Report Number
    2015691-2011-16131
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 3, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE HOSPITAL. THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. THE SURGEON'S COMMENTS INDICATED THAT THIS EXPLANT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE BUT DUE TO OVER-SIZING. WITHOUT THE ADDITIONAL EVENT INFORMATION OR RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, THE 21MM VALVE WAS EXPLANTED AT IMPLANT DUE TO OVERSIZING THE VALVE AND VENTRICULAR FIBRILLATION. IT WAS REPORTED THAT A MAGNA 3000J21 WAS IMPLANTED ON (B)(6) 2011 FOR AORTIC VALVE REPLACEMENT (AVR) TO CORRECT AORTIC STENOSIS (AS). AT THE SIZING, 113019MM WAS USED FIRST AND THERE WAS STILL SOME ROOM LEFT. A 113021MM WAS USED FOR SIZING AND IT PASSED WITHOUT PROBLEM. A MAGNA 3000J21 WAS IMPLANTED. AT THE IMPLANT, THERE WAS SEVERE CALCIFICATION OBSERVED AT VALSALVA SINUS AND AORTIC ANNULUS. AFTER THE IMPLANT, CHEST WAS CLOSED AND THE OPERATION WAS ABOUT TO BE COMPLETED, THEN VENTRICULAR FIBRILLATION (VF) OCCURRED. CARDIAC MASSAGE WAS PERFORMED; HOWEVER, THE PATIENT PULSE DID NOT COME BACK. PATIENT'S CHEST WAS RE-OPENED. THE MAGNA 3000J21 WAS EXPLANTED DUE TO VENTRICULAR FIBRILLATION (VF). CUSTOMER TRIED TO IMPLANT A ST JUDE MECHANICAL VALVE 21MM. HOWEVER, IT DID NOT FIT IN THE PATIENT ANNULUS. A ST JUDE MECHANICAL VALVE 19MM WAS IMPLANTED AS A REPLACEMENT. AFTER THE REPLACEMENT, THERE WAS NO VENTRICULAR FIBRILLATION AND THE OPERATION WAS COMPLETED. CUSTOMER COMMENT: "THIS EXPLANT WAS NOT EXPECTED BUT NOT DEVICE RELATED. THERE WAS NO PROBLEM WITH THE IMPLANT; HOWEVER, MAGNA STENT POST MIGHT DEFORM THE CALCIFIED VALSALVA SINUS AND IT MIGHT AFFECT THE CORONARY ARTERY OSTIUM. IF 19MM WAS IMPLANTED, THERE WAS NO PROBLEM." CUSTOMER ALSO COMMENTED THAT THE JUDGMENT TO CHOOSE THE LARGER SIZE VALVE TO OBTAIN LARGER EFFECTIVE ORIFICE AREA (EOA) MIGHT HAVE LED THIS EVENT TO HAPPEN. PATIENT WAS RECOVERING AS OF (B)(6) 2011. DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 S-11C1055

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R