BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3090774 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19979
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL REVIEW OF THE MEDICAL RECORDS, IT WAS LEARNED THAT THE SUBJECT DEVICE WAS IMPLANTED FOR THE PATIENT'S SEVERE MITRAL REGURGITATION. THE PATIENT REPRESENTED FOR MEDIASTINAL EXPLORATION FOR BLEEDING. THE EDWARDS VALVE WAS EXPLANTED FOR REPAIR OF ATRIOVENTRICULAR DISSOCIATION USING A PATCH. A 25 MM NON-EDWARDS PROSTHETIC VALVE WAS THEN IMPLANTED. PATIENT EXPIRED ON POD #1. THERE IS NO INFORMATION SUGGESTING THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NO OTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AT IMPLANT. UNFORTUANTELY, THE REASON FOR EXPLANT IS UNKNOWN. THE PATIENT'S MEDICAL RECORDS PROVIDED INDICATE THAT AN ATTEMPT OF MITRAL VALVE REPAIR WITH AN ANNULOPLASTY RING WAS INITIALLY ATTEMPTED. SUBSEQUENTLY, A 25 MM PROSTHETIC VALVE WAS IMPLANTED. THERE IS NO REFERENCE OF THE SUBJECT DEVICE DOCUMENTED IN THE RECORDS. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED FROM UNKNOWN CAUSES. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191346 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX 2625324

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R