BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2223847 · Received August 18, 2011

    Report

    Report Number
    3005168196-2011-00309
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    October 10, 2010
    Report Date
    July 25, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFORMATION IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A PENUMBRA POST-MARKET RETROSPECTIVE STUDY (RETROSTART). THE INFORMATION AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL THE EVENING OF (B)(6) 2010 WITH SYMPTOMS OF ACUTE STROKE INCLUDING WEAKNESS ON THE RIGHT SIDE AND APHASIA. THE PATIENT PRESENTED WITH AN (B)(6) OF 28 AND EVIDENCE OF AN OCCLUSION IN THE LEFT M1. THE PATIENT RECEIVED NO TREATMENT PRIOR OR FOLLOWING USE WITH THE PENUMBRA STROKE SYSTEM. AS REPORTED IN A REVIEW OF THE CLINICAL REPORT, THE PATIENT EXPERIENCED A VASOSPASM DURING THE PROCEDURE THAT WAS TREATED WITH VERAPAMIL. THE RELATIONSHIP WAS DEFINED AS "POSSIBLE" TO THE STUDY DEVICE AND "PROBABLE" TO THE ANGIOGRAPHIC PROCEDURE. THE EVENT WAS RESOLVED THAT SAME DAY. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00306 THROUGH 3005168196-2011-00308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention