BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3092815 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02784
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    January 1, 2011
    Report Date
    April 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.ESTIMATED DATE OF OCCURRENCE. PROCEDURES WERE BETWEEN 2010 AND 2012.THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.THE PROSTAR DEVICE REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A NEW SELF-EXPANDING TRANSCATHETER HEART VALVE AND MOTORIZED DELIVERY SYSTEM. IT WAS NOTED IN THE ARTICLE THAT THE PERCLOSE PROGLIDE OR PROSTAR XL WERE USED IN THESE PROCEDURES. IT WAS NOTED THAT A DEATH OCCURRED ON DAY 49 IN A PATIENT WHO WAS INITIALLY DOING WELL AND WAS URGENTLY READMITTED WITH SEPSIS. THE AIM OF THIS STUDY WAS TO DEMONSTRATE FEASIBILITY AND SHORT AND MIDTERM CLINICAL OUTCOMES WITH A NEW SELF-EXPANDING TRANSCATHETER HEART VALVE AND MOTORIZED DELIVERY SYSTEM. FIFTEEN (15) DEVICE IMPLANTS WERE SUCCESSFUL DEPLOYED WITH A FULLY PERCUTANEOUS APPROACH. SURVIVAL RATE WAS: 87% AT 30 DAYS, 80% AT 1 YEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194205 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SHEATH: 16FR, 18FR ASPIRIN, CLOPIDOGREL