BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 3250519 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04707
    Event Type
    Death
    Date Received
    July 26, 2013
    Date of Event
    August 1, 2009
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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, EVENT OCCURRED BETWEEN (B)(6) 2009 AND (B)(6) 2010. THIS INFORMATION WAS OBTAINED THROUGH LITERATURE REVIEW; THEREFORE, DEVICE RETURN WAS NOT PROVIDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIP WAS LODGED IN THE DEPLOYMENT DEVICE AFTER COMPLETING THE DEPLOYMENT SEQUENCE, AND THE PATIENT EXPERIENCED A RETROPERITONEAL HEMATOMA RESULTING IN HEMODYNAMIC COLLAPSE AND DEATH. AS THE NAME OF THE PHYSICIAN WHO USED THE STARCLOSE DEVICE WAS NOT PROVIDED BY THE LITERATURE REVIEW, IT IS UNKNOWN IF THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350941 STARCLOSE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death