BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 4900222 · Received July 8, 2015

    Report

    Report Number
    3008853977-2015-00285
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    March 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEMORRHAGE, VESSEL PERFORATION AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) OCCLUSION AND COMPLETE REVASCULARIZATION OF THE RIGHT PCA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. HOWEVER, 2 HOURS POST PROCEDURE, A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. NO ADDITIONAL TREATMENT WAS PROVIDED. THE PHYSICIAN STATED THAT THE SAH MAY BE CAUSED BY THE GUIDEWIRE (SUBJECT DEVICE) VESSEL PERFORATION. THIRTEEN DAYS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH IS UNCLEAR. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) OCCLUSION AND COMPLETE REVASCULARIZATION OF THE RIGHT PCA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. HOWEVER, 2 HOURS POST PROCEDURE, A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. NO ADDITIONAL TREATMENT WAS PROVIDED. THE PHYSICIAN STATED THAT THE SAH MAY BE CAUSED BY THE GUIDEWIRE (SUBJECT DEVICE) VESSEL PERFORATION. THIRTEEN DAYS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH IS UNCLEAR. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444145 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 16770848

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death TREVO RETRIEVER DEVICE (CONCENTRIC)