BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 3030862 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01915
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IN THIS CASE, THERE WAS NO PRODUCT DEFICIENCY AND PRODUCT WAS NOT RETURNED. THE PATIENT EFFECTS OF A HEMATOMA AND INFECTION ARE FORESEEABLE PATIENT EFFECTS. FISTULA AND PSEUDOANEURYSM ARE MENTIONED AS POTENTIAL ADVERSE EVENTS IN STARCLOSE INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. SEBASTIAN SIXT, MD; HANS KRANKENBERG, MD; CHARLOTTE MOHRLE, MD; MATHIAS KASPAR, MD; THILO TUBLER, MD; ALJOSCHA RASTAN, MD; KLAUS BRECHTEL, MD; ROLAND MACHARZINA, MD; FRANZ-JOSEF NEUMANN, MD; AND THOMAS ZELLER, MD. (J ENDOVASC THER 2013;20:64-73): ENDOVASCULAR TREATMENT FOR EXTENSIVE AORTOILIAC ARTERY RECONSTRUCTION: A SINGLE-CENTER EXPERIENCE BASED ON 1712 INTERVENTIONIST. MEAN AGE: (B)(6). MEAN GENDER: MALE. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION, 02/01/2013.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. REPORTEDLY, A RETROSPECTIVE DATABASE SEARCH WAS PERFORMED AND IDENTIFIED 1184 CONSECUTIVE PATIENTS WHO UNDERWENT 1712 PROCEDURES TO TREAT TARGET LESIONS IN THE DISTAL AORTA AND ILIAC ARTERIES. CLOSURE DEVICES WERE EMPLOYED WHENEVER POSSIBLE, WITH A PREFERENCE FOR THE STARCLOSE DEVICE. (B)(4). AS THE ANALYSIS WAS RETROSPECTIVE, MINOR COMPLICATIONS AT THE PUNCTURE SITE (HEMATOMA, FISTULA, AND PSEUDOANEURYSM) WERE NOT TAKEN INTO ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135017 STARCLOSE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ASPIRIN 1599 (93%), CLOPIDOGREL 1546 (90%)