BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 2051535 · Received April 7, 2011

    Report

    Report Number
    3005168196-2011-00152
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    June 1, 2010
    Report Date
    March 22, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VASOSPASM AND ACUTE OCCLUSION ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THIS TYPE OF PROCEDURE AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A (B)(4). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    THIS PT WAS TREATED FOR AN OCCLUDED RIGHT ICA ORIGINAL OCCLUSION, WITH A MAJORITY OF THE AFFECTED VESSELS BEING SUCCESSFULLY REVASCULARIZED (TIMI 2). ON AN IMMEDIATE F/U ANGIOGRAM, A MINOR NON-FLOW LIMITING VASOSPASM WAS NOTED IN THE RIGHT M1 AND M2 BRANCH. ADDITIONALLY, A LATERAL ANGIOGRAM DEMONSTRATED A NON-OPACIFIED PERICALLOSAL ARTERY SUGGESTING A NEW OCCLUSION OF A PREVIOUSLY UNAFFECTED TERRITORY. THE PHYSICIAN REVIEWING THE SCAN FELT THE VASOSPASM WAS POSSIBLY RELATED TO THE PENUMBRA SYSTEM, BUT THE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE WAS UNCERTAIN. THE OCCLUSION OF THE PERICALLOSAL ARTERY WAS POSSIBLY RELATED TO THE PENUMBRA SYSTEM, BUT UNRELATED TO THE ANGIOGRAPHIC PROCEDURE. BOTH EVENTS WERE DEEMED NON-SERIOUS ADVERSE EVENTS REQUIRING NO ADDITIONAL ACTION AND RESOLVING ON THE SAME DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other