BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 054

    MDR report key: 1980375 · Received February 3, 2011

    Report

    Report Number
    3005168196-2011-00016
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 19, 2010
    Report Date
    January 7, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VESSEL SPASM IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFO PROVIDED IN THIS COMPLAINT WAS DISCOVERED DURING A REVIEW OF DATA COLLECTED DURING A PENUMBRA POST-MARKET CLINICAL TRIAL. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PT PRESENTED TO THE HOSPITAL ABOUT 6.5 HOURS AFTER THE TIME HE WAS LAST KNOWN TO BE WELL. THERE WAS A 99% OCCLUSION OF THE TERMINUS OF THE RIGHT ICA. THE PROCEDURAL REPORT INDICATES THAT A COAXIAL MICROCATHETER SYSTEM WAS USED TO ACCESS THE LEVEL OF THE CLOT BUT THERE IS ONLY EVIDENCE OF THE PENUMBRA SYSTEM 054 BEING USED. THE PT WAS GIVEN 2 MG OF IA TPA PRIOR TO ASPIRATION WITH THE PENUMBRA SYSTEM 054. SUCTION EMBOLECTOMY WAS USED WITH THE 054 SYSTEM, SUCCESSFULLY REVASCULARIZING THE RIGHT ICA AND M1 ABOUT 5 MINUTES. A FOLLOW UP ANGIOGRAM REVEALED THAT THE M1 SEGMENT WAS DIFFUSELY NARROWED IN A SMOOTH FASHION WHICH HAD THE APPEARANCE MOST SUGGESTIVE OF VASOSPASM. THE TREATING PHYSICIAN/PI DETERMINE THAT THE VASOSPASM WAS MODERATE IN SEVERITY AND DEFINITELY RELATED TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE. NO ACTIONS WERE TAKEN AND THE VASOSPASM RESOLVED ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM 054 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F17604

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other