BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2123882 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04176
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    July 29, 2010
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE REPORTED DEVICE MALFUNCTION COULD NOT BE DETERMINED. A SPECIFIC MODE OF DEVICE FAILURE WAS NOT REPORTED IN THIS CASE; HOWEVER, AN UNDESIRABLE PROCEDURAL EVENT THAT RESULTS IN AN INABILITY TO ACHIEVE HEMOSTASIS CAUSES A LOSS OF BLOOD AND MAY REQUIRE BLOOD TRANSFUSION. THIS INCLUDES, BUT IS NOT LIMITED TO PATIENT ANATOMY, USER TECHNIQUE AND MANUFACTURING. THE INFORMATION PROVIDED BY THE CUSTOMER IS LIMITED AND DOES NOT ALLOW FOR ASSIGNING A CONTRIBUTING FACTOR TO THE EXPERIENCED EVENT. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER IMPLANTATION OF A NON-ABBOTT AORTIC VALVE PROTHESIS. REPORTEDLY, AN UNSPECIFIED DEVICE MALFUNCTION OCCURRED. THE PATIENT WAS TAKEN TO SURGERY AND REQUIRED TRANSFUSION OF 8 UNITS OF BLOOD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention EDWARDS LIFESCIENCES AORTIC VALVE PROSTHESIS