BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3- 4.0 X 20MM

    MDR report key: 3072023 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00125
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 1, 2008
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. THE PATIENT WAS TREATED BETWEEN (B)(6) 2008 AND (B)(6) 2012. SUBJECT DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, VESSEL THROMBOSIS IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE IN NEUROSURGERY REPORTED THAT A RETROSPECTIVE STUDY WAS CONDUCTED FOR PATIENTS TREATED FOR BLISTER-LIKE ANEURYSMS (BLAS). IT WAS REPORTED THAT A PATIENT UNDERWENT STENT PLACEMENT ACROSS THE BLA LOCATED IN THE LEFT SUPRACLINOID ICA. IMMEDIATELY POST STENT PLACEMENT STAGNATION OF BLOOD FLOW WITHIN THE ANEURYSM WAS OBSERVED RESULTING IN THROMBUS FORMATION AROUND THE STENT TINES. THE PATIENT WAS TREATED WITH AN ABCIXIMAB BOLUS AND INFUSION (DOSE UNKNOWN). OF NOTE, THE PATIENT WAS NOT PRE-TREATED WITH ASPIRIN OR CLOPIDOGREL. REPEAT ANGIOGRAPHY SEVEN DAYS POST PROCEDURE DEMONSTRATED DECREASED ANEURYSM FILLING WITHOUT ANY EVIDENCE OF THROMBOSIS. THE PATIENT WAS DISCHARGED IN GOOD NEUROLOGIC CONDITION. FOLLOW-UP CTA 4.5 MONTHS LATER SHOWED COMPLETE ANEURYSM OCCLUSION. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE IN NEUROSURGERY REPORTED THAT A RETROSPECTIVE STUDY WAS CONDUCTED FOR PATIENTS TREATED FOR BLISTER-LIKE ANEURYSMS (BLAS). IT WAS REPORTED THAT A PATIENT UNDERWENT STENT PLACEMENT ACROSS THE BLA LOCATED IN THE LEFT SUPRACLINOID ICA. IMMEDIATELY POST STENT PLACEMENT STAGNATION OF BLOOD FLOW WITHIN THE ANEURYSM WAS OBSERVED RESULTING IN THROMBUS FORMATION AROUND THE STENT TINES. THE PATIENT WAS TREATED WITH AN ABCIXIMAB BOLUS AND INFUSION (DOSE UNKNOWN). OF NOTE, THE PATIENT WAS NOT PRE-TREATED WITH ASPIRIN OR CLOPIDOGREL. REPEAT ANGIOGRAPHY SEVEN DAYS POST PROCEDURE DEMONSTRATED DECREASED ANEURYSM FILLING WITHOUT ANY EVIDENCE OF THROMBOSIS. THE PATIENT WAS DISCHARGED IN GOOD NEUROLOGIC CONDITION. FOLLOW-UP CTA 4.5 MONTHS LATER SHOWED COMPLETE ANEURYSM OCCLUSION. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172476 NEUROFORM 3- 4.0 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other