BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT

    MDR report key: 1727174 · Received June 17, 2010

    Report

    Report Number
    2939204-2010-00743
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE ALL MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON RELEASE. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. VESSEL DISSECTION AND THE PATIENT OUTCOME OF DEATH 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

    THE PATIENT PRESENTED WITH A STROKE AND WAS SYMPTOMATIC OF AN OCCLUDED BASILAR ARTERY. THE PHYSICIAN ENCOUNTERED DIFFICULTY ACCESSING THE BASILAR ARTERY THROUGH THE LEFT VERTEBRAL ARTERY BUT WAS ABLE TO SUCCESSFULLY PERFORM ANGIOPLASTY AND IMPLANT A STENT. A DISSECTION WAS NOTED IN THE LEFT VERTEBRAL ARTERY. THE PHYSICIAN STATED "THE DISSECTION WAS NOT RELATED TO THE BALLOON OR THE STENT. THEY PHYSICIAN SAID THE PATIENT HAD A GREAT ANGIOGRAPHIC OUTCOME AND FELT THE DISSECTION WAS CAUSED BY THE OCCLUDED ARTERY." THE PATIENT DIED SHORTLY AFTER THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A STROKE AND WAS SYMPTOMATIC OF AN OCCLUDED BASILAR ARTERY. THE PHYSICIAN ENCOUNTERED DIFFICULTY ACCESSING THE BASILAR ARTERY THROUGH THE LEFT VERTEBRAL ARTERY BUT WAS ABLE TO SUCCESSFULLY PERFORM ANGIOPLASTY AND IMPLANT A STENT. A DISSECTION WAS NOTED IN THE LEFT VERTEBRAL ARTERY. THE PHYSICIAN STATED "THE DISSECTION WAS NOT RELATED TO THE BALLOON OR THE STENT. THEY PHYSICIAN SAID, THE PATIENT HAD A GREAT ANGIOGRAPHIC OUTCOME AND FELT THE DISSECTION WAS CAUSED BY THE OCCLUDED ARTERY." THE PATIENT DIED SHORTLY AFTER THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT WAS SYMPTOMATIC FOR AN OCCLUDED BASILAR ARTERY. THE ANGIOPLASTY AND STENTING OF THE BASILAR OCCLUSION HAD AN EXCELLENT ANGIOGRAPHIC RESULT WITHIN THE BASILAR ARTERY, RESTORING ANTEGRADE FLOW. THE PROCEDURE WAS COMPLICATED BY DIFFICULT ACCESS OF THE BASILAR ARTERY VIA A TORTUOUS CERVICAL LEFT VERTEBRAL ARTERY, WITH AN IATROGENIC DISSECTION REQUIRING STENT PLACEMENT AT THE END OF THE PROCEDURE. THE PHYSICIAN STATED "THE DISSECTION WAS NOT RELATED TO THE BALLOON OR THE STENT. THEY PHYSICIAN SAID THE PATIENT HAD A GREAT ANGIOGRAPHIC OUTCOME AND FELT THE DISSECTION WAS CAUSED BY THE OCCLUDED ARTERY." THE PATIENT FAILED TO WAKE FROM THE GENERAL ANESTHESIA WITH NO SPONTANEOUS RESPIRATION AND REMAINED INTUBATED WHEN SENT TO THE INTENSIVE CARE UNIT. THE PATIENT CONTINUED TO SHOW SIGNS OF A BRAIN STEM STROKE WITH QUADRIPLEGIA, ABNORMAL OCULAR MOVEMENTS, LABILE BLOOD PRESSURE AND HEART RATE AND NO SPONTANEOUS RESPIRATIONS. A CT SCAN SHOWED EVIDENCE OF A BRAIN STEM ISCHEMIC EVENT. THE ISCHEMIC INSULT TO THE BRAIN WAS SEVERE AND APPEARED TO REPRESENT A GLOBAL INSULT RATHER THAN AN EMBOLIC/PERFORATOR EVENT. THE LIKELY ETIOLOGY WAS PROLONGED ISCHEMIA DURING CATHETERIZATION OF THE LEFT VERTEBRAL ARTERY AND/OR DISSECTION OF THE CERVICAL VERTEBRAL ARTERY. THE ADVERSE EVENT IS UNLIKELY DIRECTLY RELATED TO THE STENT PLACED IN THE BASILAR ARTERY. THE PATIENT'S FAMILY CHOSE TO WITHDRAW CARE BASED ON THE PROGNOSIS AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT UNK484

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| O| R GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)