BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 3190691 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03993
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 1, 2011
    Report Date
    June 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF OCCURRENCE ESTIMATED AS (B)(4) 2011 AS THE STUDY WAS CONDUCTED BETWEEN (B)(6) 2006 AND (B)(6) 2011. THE DEVICES WERE REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    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 CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE-CENTER, PROSPECTIVE OBSERVATIONAL STUDY IDENTIFIED 250 PATIENTS WHO UNDERWENT TAVI (TRANSCATHETER AORTIC VALVE IMPLANTATION) BETWEEN (B)(6) 2006 AND (B)(6) 2011. TRANSFEMORAL ACCESS WAS USED IN 190 CASES. SEVENTY EIGHT PATIENTS RECEIVING THE SAPIEN VALVE TRANSFEMORAL HAD A SURGICAL ACCESS. PATIENTS RECEIVING THE SAPIEN XT VALVE TRANSFEMORAL HAD A PERCUTANEOUS ACCESS. PERCUTANEOUS FEMORAL ACCESS WAS USED IN 112 CASES. PERCUTANEOUS FEMORAL ACCESS CASES WERE CLOSED USING THE PROSTAR DEVICE. TWENTY OF THE CASES WITH PROSTAR CLOSURE WERE REPORTED TO HAVE LIFE THREATENING BLEEDING. CLINICAL OUTCOMES INVOLVING BLEEDING FOR ALL PATIENTS WERE AS FOLLOWS: BLEEDING COMPLICATIONS - 69 PATIENTS. LIFE THREATENING BLEEDING - 33 PATIENTS; MAJOR BLEEDING - 24 PATIENTS; MINOR BLEEDING - 12 PATIENTS. FEMORAL ACCESS BLEEDING: REQUIRING A STENT GRAFT IMPLANTATION - 12 PATIENTS. URGENT VASCULAR SURGERY - 6 PATIENTS. RED BLOOD CELL TRANSFUSION (AT LEAST ON UNIT) - 88 PATIENTS. TRANSFUSION (UNIDENTIFIED SOURCE OF BLEEDING) - 35 PATIENTS. A CORRELATION BETWEEN PROSTAR DEVICE USE AND ANY OF THESE EVENTS WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290404 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 18F, 19F