BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC DETACHABLE COIL

    MDR report key: 1479343 · Received September 17, 2009

    Report

    Report Number
    2939204-2009-00744
    Event Type
    Injury
    Date Received
    September 17, 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

    ALL THE PROCEDURES IN THE ARTICLE WERE CONDUCTED BETWEEN 1998 AND 2003. ADD'L PMA/510(K): K042539.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT "SIXTY-TWO OF 1036 ANEURYSMS [929 PTS] 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)." FOR FIVE PTS, ENDOVASCULAR RETREATMENT WAS INSUFFICIENT AND THE PT WAS INEVITABLY REFERRED FOR OPEN SURGICAL CLIPPING." THIS REPORT IS FOR THE PT FOR WHOM THE SURGICAL CLIPPING PROCEDURE WAS NOT COMPLETED, THE REASON WAS NOT DISCLOSED. IN THIS PT A NEW RECANALIZATION OR DE NOVO ANEURYSM WAS OBSERVED. THIS PT SUBSEQUENTLY RE-BLED AFTER THE FAILURE OF THE SURGERY. IT WAS NOT STATED WHEN THE BLEED OCCURRED OR HOW LONG AFTER THE SURGICAL ATTEMPT IT OCCURRED. THE PT WAS RETREATED BY ENDOVASCULAR TREATMENT IN THE EMERGENCY DEPT WITH A POOR CLINICAL OUTCOME. NO OTHER INFO WAS PROVIDED AS TO THE NATURE OF THE POOR CLINICAL OUTCOME.

    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