BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1104428 · Received August 7, 2008

    Report

    Report Number
    2939204-2008-00317
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    October 1, 2007
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT DISCLOSED. NO ALLEGED DEVICE MALFUNCTION. CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE BATCH NUMBER OF THE SUBJECT DEVICE WAS NOT INITIALLY DISCLOSED. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND SIMILAR COMPLAINT REVIEW WAS UNABLE TO BE PERFORMED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT THEREFORE IS UNAVAILABLE FOR INVESTIGATION. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM AN ISCHEMIC STROKE APPROXIMATELY 10 MONTHS FOLLOWING PROCEDURE. IT SHOULD BE NOTED THAT THE STENT WAS PLACED SUCCESSFULLY WITH NO COMPLICATIONS AND NO REPORT OF MALFUNCTION OR SPECIFICATION NONCONFORMANCE. THERE IS ALSO NO INDICATION THAT THE DEVICE WAS MISUSED BY THE PHYSICIAN. STROKE IS AN ANTICIPATED POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND DISEASE STATE AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE FOR THIS DEVICE. AS A RESULT, THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO ANTICIPATED PROCEDURAL COMPLICATIONS INDICATIVE OF THESE TYPES OF PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TREATMENT WITH A STENT FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) IN THE MI SEGMENT OF THE IN THE RIGHT MIDDLE CEREBRAL ARTERY IN 2005. PREDILATION WITH BALLOON CATHETER WAS PERFORMED, THEN STENT WAS IMPLANTED. PRE-PROCEDURE STENOSIS WAS 90%, RESIDUAL STENOSIS FOLLOWING THE PROCEDURE WAS 0%. NO COMPLICATIONS LISTED DURING PROCEDURE. THE PATIENT REPORTEDLY HAD AN ISCHEMIC STROKE IN 2006, THAT REQUIRED HOSPITALIZATION WITH REVASCULARIZATION THREE DAYS LATER. PATIENT CONDITION IS REPORTED TO BE ONGOING UNRESOLVED. NO FURTHER DETAILS HAVE BEEN DISCLOSED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION WS030020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R