BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREVO PROVUE

    MDR report key: 3030752 · Received April 2, 2013

    Report

    Report Number
    0002954917-2013-00040
    Event Type
    Death
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K122478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Additional Manufacturer Narrative · 1

    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 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 AND PATIENT COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED ONE PASS WITH THE RETRIEVAL DEVICE. HOWEVER, AS THE PHYSICIAN ATTEMPTED TO PERFORM THE SECOND PASS, THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) AND 'PASSED AWAY ON THE TABLE.' THE PHYSICIAN STATED THAT THE CAUSE OF THE PATIENT DEATH WAS THE SAH. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED ONE PASS WITH THE RETRIEVAL DEVICE. HOWEVER, AS THE PHYSICIAN ATTEMPTED TO PERFORM THE SECOND PASS, THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) AND "PASSED AWAY ON THE TABLE". THE PHYSICIAN STATED THAT THE CAUSE OF THE PATIENT DEATH WAS THE SAH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134799 TREVO PROVUE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death TREVO PRO 18RO MICROCATHETER (CONCENTRIC)