BEUDAMED
    FDA Adverse Event Death Summary report: N

    F/G WINGSPAN STENT SYSTEM 2.5 X 9MM

    MDR report key: 6170154 · Received December 13, 2016

    Report

    Report Number
    3008881809-2016-00303
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    July 30, 2015
    Report Date
    March 1, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, HEMORRHAGE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT. THIS IS THE 2ND OF 2 REPORTS (SEE MFR REPORT # 0002134265-2016-00035).

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTA) AT 9 ATM FOR 30 SECONDS FOR A LEFT MCA STENOSIS (91.6% OCCLUSION AND LESION LENGTH OF 4.6MM) WITH A PTA BALLOON CATHETER, DISSECTION OCCURRED AT THE LESION LOCATION. MEDICAL INTERVENTION WAS PERFORMED BY PLACEMENT OF A STENT SYSTEM (SUBJECT DEVICE). HYPERPERFUSION WAS OBSERVED IMMEDIATELY AFTER ANGIOGRAPHY. FIVE HOURS AND A HALF POST- PROCEDURE THE PATIENT DEVELOPED PUTAMINAL HEMORRHAGE AND EXPIRED. NO MEDICAL TREATMENT WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE (PTA) AT 9 ATM FOR 30 SECONDS FOR A LEFT MCA STENOSIS (91.6% OCCLUSION AND LESION LENGTH OF 4.6MM) WITH A PTA BALLOON CATHETER, DISSECTION OCCURRED AT THE LESION LOCATION. MEDICAL INTERVENTION WAS PERFORMED BY PLACEMENT OF A STENT SYSTEM (SUBJECT DEVICE). HYPERPERFUSION WAS OBSERVED IMMEDIATELY AFTER ANGIOGRAPHY. FIVE HOURS AND A HALF POST- PROCEDURE, THE PATIENT DEVELOPED PUTAMINAL HEMORRHAGE AND EXPIRED. NO MEDICAL TREATMENT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821625 F/G WINGSPAN STENT SYSTEM 2.5 X 9MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 17604033

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O GATEWAY BALLOON CATHETER (STRYKER)