BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 STENT DELIVERY SYSTEM

    MDR report key: 1192763 · Received October 8, 2008

    Report

    Report Number
    2939204-2008-00451
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED WITH A WIDE NECK PERIOPHTHALMIC ARTERY ANEURYSM. THE PHYSICIAN ACCESSED THE LESION WITH STENT DELIVERY SYSTEM AND GUIDEWIRE. BEFORE PLACING THE STENT, THE PHYSICIAN DEPLOYED A NON BOSTON SCIENTIFIC COIL INTO THE ANEURYSM. AS THIS COIL WAS BEING DEPLOYED, THE LEADING EDGE OF THE COIL PASSED THROUGH THE DOME OF THE ANEURYSM. THE COIL WAS LEFT IN PLACE AND THE STENT DEPLOYED. EMBOLIZATION OF THE ANEURYSM CONTINUED USING A SECOND MICROCATHETER AND ADD'L COILS. IT WAS REPORTED THAT MID WAY THROUGH THIS PART OF THE PROCEDURE, ANGIOGRAPHY REVEALED A CLOT FORMATION WITHIN THE LUMEN OF THE STENT AND REOPRO WAS ADMINISTERED. THE EMBOLIZATION WAS COMPLETED AND THE SECOND MICROCATHETER WAS WITHDRAWN, ANGIOGRAPHY SHOWED A STABLE CLOT. FOLLOWING THE CONCLUSION OF THE PROCEDURE, A CT SCAN WAS PERFORMED THAT DEMONSTRATED THERE WAS NO THROMBUS IN THE LUMEN OF THE STENT OR EVIDENCE OF HEMORRHAGE, DUE TO THE RUPTURED ANEURYSM. THE PT WAS REPORTED TO TOLERATE THE PROCEDURE WELL WITH "A NORMAL POSTOPERATIVE COURSE" AND WAS SUBSEQUENTLY DISCHARGED FROM HOSPITAL IN A "STABLE CONDITION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 STENT DELIVERY SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. SNF34020 9187055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORDIS ULTIPAQ 10 COIL| THREE BOSTON SCIENTIFIC TRANSEND GUIDEWIRES| MANUFACTURER UNK.| THE PT WAS HEPARINIZED| DOSE NOT PROVIDED.| AND TWO ECHELON 10 MICROCATHETERS.| TWO TRUFILL COILS| TWO HELIPAQ COILS| AND TWO MICROPLEX COILS