BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1479119 · Received September 16, 2009

    Report

    Report Number
    2939204-2009-00739
    Event Type
    Injury
    Date Received
    September 16, 2009
    Report Date
    September 4, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE IS UNKNOWN; ALL THE PROCEDURE IN THE ARTICLE WERE CONDUCTED BETWEEN 1998 AND 2003. REPORT SOURCE: GALLAS S. AJNR, 2009 SEP 3. ADD'L 510K: K042539.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT "SIXTY-TWO OF 1036 ANEURYSM [929 PATIENTS] WERE RETREATED ONE OR MORE TIMES FOR A TOTAL OF 72 NEW PROCEDURES (53 ANEURYSMS WERE RETREATED ONCE; 8 ANEURYSMS TWICE AND 1 ANEURYSM THREE TIMES DURING THE FOLLOW UP PERIOD)." IT IS NOT CLEAR FROM THE ARTICLE HOW MANY PATIENTS WERE AFFECTED AS THERE WERE 929 PATIENTS ENROLLED IN THE STUDY AND 1036 ANEURYSMS WERE TREATED FROM THESE PATIENTS. ADDITIONALLY, SOME OF THE ANEURYSM UNDERWENT MULTIPLE RE-TREATMENTS. THERE WAS NO REPORTED CLINICAL CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC DETACHABLE COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention