BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 STENT SYSTEM

    MDR report key: 1081643 · Received July 23, 2008

    Report

    Report Number
    2939204-2008-00301
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 10, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN AS THE UPN AND BATCH NUMBERS WERE NOT DISCLOSED. FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NONCONFORMANCE. OTHER: INTERVENTIONAL NEURORADIOLOGY PEER REVIEW CONFERENCE.

    Description of Event or Problem · 1

    AT A PEER REVIEW CONFERENCE, THE FOLLOWING EVENT WAS REPORTED REGARDING A CASE CONDUCTED OVER TWO YEARS AGO. THE PT PRESENTED WITH A RIGHT PSEUDO-ANEURYSM AT THE VERTEBRASILAR JUNCTION THAT WAS ACCESSED VIA THE RIGHT VERTEBRAL ARTERY. A STENT AND THREE COILS WERE PLACED DURING THE EMBOLIZATION PROCEDURE WITHOUT ANY REPORTED ISSUE, AND THE PT WAS GIVEN 2000U OF HEPARIN FOLLOWING THE STENT PLACEMENT. A FINAL ANGIOGRAM SHOWED EVIDENCE OF A SUBARACHNOID HEMORRHAGE DUE TO RUPTURE OF THE PSEUDO-ANEURYSM. FURTHER INFO WAS REQUESTED, BUT THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 STENT SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THREE COILS