BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 3.5 X 15MM

    MDR report key: 4200468 · Received October 24, 2014

    Report

    Report Number
    3008853977-2014-00339
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, HEMORRHAGE AND NEUROLOGICAL SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    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, HEMORRHAGE, STROKE, AND NEUROLOGICAL SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST STENTING PROCEDURE THE PATIENT WAS ADMITTED WITH CONVULSIONS. CT SCAN PERFORMED REVEALED EXTENSIVE HEMORRHAGE IN THE AREA OF TREATMENT AND A CRANIOTOMY PROCEDURE WAS PERFORMED IN RESPONSE TO THE EVENT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE RELATIONSHIP OF THE PATIENT'S OUTCOME AND THE IMPLANTED STENT. HOWEVER, HE FEELS THAT THERE IS ALSO THE POSSIBILITY THAT THE ANTIPLATELET MEDICATION CONTRIBUTED TO THE PATIENT'S HEMORRHAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST STENTING PROCEDURE THE PATIENT WAS ADMITTED WITH CONVULSIONS. CT SCAN PERFORMED REVEALED EXTENSIVE HEMORRHAGE IN THE AREA OF TREATMENT. STROKE WAS ALSO NOTED. A CRANIOTOMY PROCEDURE WAS PERFORMED IN RESPONSE TO THE EVENT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE RELATIONSHIP OF THE PATIENT'S OUTCOME AND THE IMPLANTED STENT. HOWEVER, HE FEELS THAT THERE IS ALSO THE POSSIBILITY THAT THE ANTIPLATELET MEDICATION CONTRIBUTED TO THE PATIENT'S HEMORRHAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST STENTING PROCEDURE THE PATIENT WAS ADMITTED WITH CONVULSIONS. CT SCAN PERFORMED REVEALED EXTENSIVE HEMORRHAGE IN THE AREA OF TREATMENT AND A CRANIOTOMY PROCEDURE WAS PERFORMED IN RESPONSE TO THE EVENT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE RELATIONSHIP OF THE PATIENT'S OUTCOME AND THE IMPLANTED STENT. HOWEVER, HE FEELS THAT THERE IS ALSO THE POSSIBILITY THAT THE ANTIPLATELET MEDICATION CONTRIBUTED TO THE PATIENT'S HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678369 F/G WINGSPAN STENT SYSTEM 3.5 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R