BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER TRANSFORM SUPERCOMPLIANT OCCLUSION BALLOON CATHETER

    MDR report key: 12834952 · Received November 17, 2021

    Report

    Report Number
    MW5105402
    Event Type
    Death
    Date Received
    November 17, 2021
    Date of Event
    November 6, 2021
    Report Date
    November 16, 2021
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS BROUGHT FOR BALLOON ANGIOPLASTY OF THE LEFT A1 AND M1 DUE TO SEVERE POST-SUBARACHNOID HEMORRHAGE VASOSPASM. A 3X5MM TRANSFORM BALLOON OVER A SYNCHRO SELECT SOFT MICROWIRE WAS BROUGHT INTO THE M1 AND INFLATED WITH SUCCESSFUL TREATMENT OF THE M1. IT WAS THEN POSITIONED IN THE A1 AND THE PROXIMAL STENOSIS WAS SUCCESSFULLY DILATED. THE BALLOON WAS THEN PUSHED SLIGHTLY MORE DISTALLY INTO THE A1 AND INFLATED WITH THE WIRE WELL INTO THE A2. AT THIS TIME, THERE WAS NO CONTRAST FILLING INTO THE BALLOON BUT THE BALLOON INFLATED AND RUPTURED THE LEFT A1. THE BALLOON WAS SUBSEQUENTLY WITHDRAWN INTO THE INTERNAL CAROTID ARTERY AND TEST INFLATED THERE WITH SUBOPTIMAL VISUALIZATION. THE PATIENT'S INTRACRANIAL PRESSURE CLIMBED TO THE 170S AND SHE WAS ULTIMATELY DECLARED BRAIN DEAD. ON FURTHER EXAMINATION AFTER THE CASE, THE BALLOON WAS FOUND TO STILL BE INTACT. THIS FINDING IS CONCERNED FOR POSSIBLE BLOOD ENTERING THE TRANSFORM BALLOON DESPITE THE WIRE BEING IN PLACE THEREBY PREVENTING CONTRAST FROM FILLING THE BALLOON AND OBSCURING VISUALIZATION OF ITS DEGREE OF INFLATION. DURATION: 2 HOURS, NOT ONGOING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724568 STRYKER TRANSFORM SUPERCOMPLIANT OCCLUSION BALLOON CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR 22359296

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Death 0.014 IN SYNCHRO SOFT MICROWIRE