BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 836321 · Received April 3, 2007

    Report

    Report Number
    6000078-2007-00102
    Event Type
    Injury
    Date Received
    April 3, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 7, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #: H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC IN 2007 THAT THE "STENT WAS PRE-INFLATED IN VETEBRAL ARTERY, WHICH WAS LOCATED AT 15CM BEFORE REACHING BASILAR TIP. PHYSICIAN THOUGHT THAT THE VESSEL ANATOMY WAS VERY TORTUOUS, SO WIRE (SILVERSPEED WIRE MADE BY EV3) AND STENT WERE PUSHED BY SOME TENSION. STENT CANNOT BE RETRIEVED FROM THE PT'S BODY AND ANEURYSM PACKING WAS COMPLETED WITH COIL ONLY. THE SIZE OF ANEURYSM WAS ABOUT 9MM." THIS WAS A STENT ASSISTED ANEURYSM COILING PROCEDURE OF A BASILAR TIP ANEURYSM. IT WAS REPORTED THAT THERE WERE NO PT COMPLICATIONS, AND THAT THE PT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - INTRACRANIAL NEUROVASCULAR STENT NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION SNF34020 9304460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SILVERSPEED WIRE (NON-BSC)| COIL (UNKNOWN MFR)