BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 3517887 · Received December 12, 2013

    Report

    Report Number
    2024168-2013-07953
    Event Type
    Injury
    Date Received
    December 12, 2013
    Date of Event
    January 2, 2009
    Report Date
    November 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. (B)(4). THE DEVICES ARE NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. ARTICLE: HITINDER S. GURM, MD; CARRIE HOSMAN, PHD; DAVID SHARE, MD; MAURO MOSCUCCI, MD; AND BEN B. HANSEN, PHD. (ANNALS OF INTERNAL MEDICINE 159.1, NOV 19, 2013: 660-6.) COMPARATIVE SAFETY OF VASCULAR CLOSURE DEVICES AND MANUAL CLOSURE AMONG PATIENTS HAVING PERCUTANEOUS CORONARY INTERVENTION.

    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

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE: "COMPARATIVE SAFETY OF VASCULAR CLOSURE DEVICES AND MANUAL CLOSURE AMONG PATIENTS HAVING PERCUTANEOUS CORONARY INTERVENTION. " IT WAS REPORTED THAT A MULTI-CENTER RETROSPECTIVE STUDY IDENTIFIED 85,048 CONSECUTIVE PATIENTS WHO UNDERWENT PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURES BETWEEN 2007- 2009. OF THE 85,048 PROCEDURES, 28,528 USED VESSEL CLOSURE DEVICES, 9.7% WERE PERCLOSE DEVICES, 9.5% WERE STARCLOSE DEVICES. NO STUDY INFORMATION WAS PROVIDED ON DEVICE FAILURES. THE ARTICLE DID NOT INDICATE A DIRECT CORRELATION BETWEEN THE ADVERSE PATIENT OUTCOMES AND THE PERCLOSE AND STARCLOSE DEVICES. CLINICAL OUTCOMES WERE AS FOLLOWS: HEMATOMA, PSEUDOANEURYSM, RETROPERITONEAL BLEEDING, BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650393 STARCLOSE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention