BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM STENT

    MDR report key: 1952916 · Received January 7, 2011

    Report

    Report Number
    2939204-2010-01166
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE ALL MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS RETURNED WITH THE GUIDEWIRE USED IN THE PROCEDURE. INSPECTION OF THE MICRODELIVERY CATHETER NOTED THAT IT WAS SLIGHTLY COMPRESSED 6CM FROM THE DISTAL END. INSPECTION OF THE STABILIZER NOTED THAT IT WAS BENT ON ITS PROXIMAL SHAFT. THE STENT WAS IN THE MICRODELIVERY CATHETER WITH THE STABILIZER BUTTED UP AGAINST ITS PROXIMAL END, IT WAS DEPLOYED ON THE TABLE AND NO ANOMALIES WERE NOTED. NO ANOMALIES WERE NOTED TO THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED VESSEL RUPTURE AND INTRACRANIAL HEMORRHAGE. VESSEL RUPTURE AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE MANIPULATION OF THE DEVICES THE POSTERIOR COMMUNICATING ARTERY RUPTURED. PROTAMINE WAS GIVEN, DOSE WAS NOT DISCLOSED, TO REVERSE THE ANTI-COAGULATION IN RESPONSE TO THE RUPTURE AND THE PATIENT SUFFERED AN INTRACRANIAL HEMORRHAGE. THE PATIENT WAS REPORTED TO BE "NOT DOING WELL" IMMEDIATELY AFTER THE EVENT AND NO OTHER INFORMATION WAS PROVIDED AS TO THE CURRENT CONDITION OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE MANIPULATION OF THE DEVICES THE POSTERIOR COMMUNICATING ARTERY RUPTURED. PROTAMINE WAS GIVEN, DOSE WAS NOT DISCLOSED, TO REVERSE THE ANTI-COAGULATION IN RESPONSE TO THE RUPTURE AND THE PATIENT SUFFERED AN INTRACRANIAL HEMORRHAGE. THE PATIENT WAS REPORTED TO BE "NOT DOING WELL" IMMEDIATELY AFTER THE EVENT AND NO OTHER INFORMATION WAS PROVIDED AS TO THE CURRENT CONDITION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003SNF340200 13630140

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SYNCHRO GUIDEWIRE (BOSTON SCIENTIFIC)