BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 882140 · Received July 16, 2007

    Report

    Report Number
    6000078-2007-00198
    Event Type
    Injury
    Date Received
    July 16, 2007
    Date of Event
    June 18, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLOT WAS FOUND ON DEVICE OUTSIDE OF PATIENT. ADD'L PMA: H020002/S5. THE DEVICE DIRECTIONS FOR USE (DFU) STATES: "TYPICAL ANTIPLATELET AND ANTICOAGULATION REGIMEN USED FOR INTERVENTIONAL INTRACRANIAL PROCEDURE IS RECOMMENDED AT THE DISCRETION OF THE TREATING PHYSICIAN." AS WELL, CONTRAINDICATIONS FOR THIS DEVICE INCLUDE "PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULATION THERAPY IS CONTRAINDICATED." FINALLY, PER THE DFU PRECAUTIONS: "IN TORTUOUS VESSELS, A STIFF GUIDEWIRE MAY CAUSE BINDING WITHIN THE NEUROFORM MICRODELIVERY STENT SYSTEM DURING DEPLOYMENT. IN SUCH CASES, USE ONLY SOFT GUIDEWIRES, AND POSITION THE FLOPPY SECTION OF THE GUIDEWIRE WITHIN THE STENT."

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, A STENTING PROCEDURE OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT WAS "HEPARINIZED, BUT NOT ANTI-AGGREGATED (NOT WITH CLOPIDOGREL)." FOLLOWING TWO UNSUCCESSFUL ATTEMPTS AT STENTING, THE PHYSICIAN PLACED THE STENT (SUBJECT DEVICE) AT THE TARGET LOCATION OF THE ANEURYSM, AND ATTEMPTED DELIVERY. DUE TO FRICTION AND A "...VERY HARD" GUIDEWIRE, THE STABILIZER WOULD NOT SLIDE, AND THE STENT COULD NOT BE DEPLOYED. UPON REMOVAL OF THE SYSTEM, THE GUIDEWIRE WAS STUCK TO THE MICROCATHETER WITH A CLOT. THE CLOT WAS OBSERVED OUTSIDE THE PATIENT WHEN TRYING TO REMOVE THE GUIDEWIRE FROM THE MICROCATHETER. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THIS PROCEDURE. THE PHYSICIAN CHOSE TO SEND THE PATIENT TO NEUROSURGERY FOLLOWING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - INTRACRANIAL, NEUROVASCULAR STENT NJE BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV E345020 8927052

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR GUIDEWIRE (UNKNOWN MFG)