BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 054

    MDR report key: 2042012 · Received March 31, 2011

    Report

    Report Number
    3005168196-2011-00127
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    September 16, 2010
    Report Date
    March 16, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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 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

    PT WAS FOUND FACE DOWN WITH LEFT SIDED HEMIPLEGIA. HE WAS TRANSFERRED FROM AN OUTSIDE HOSP AND UPON PRESENTATION TO COTTAGE HOSP HAD A BASELINE NIHSS OF 18. BASELINE IMAGING REVEALED COMPLETE OCCLUSION OF THE RIGHT ICA (PETROUS, CAVERNOUS, AND SUPRACLINOID SEGMENTS) AS WELL AS THE A1 SEGMENT OF THE RIGHT ACA. ANGIOGRAMS ALSO REVEALED THAT THROMBUS INVOLVED THE M1 AND M2 SEGMENTS OF THE MCA. THE PENUMBRA SYSTEM 054 AND PENUMBRA SYSTEM 032 WERE ADVANCED DISTALLY IN A TRIAXIAL FASHION AND ASPIRATION WAS PERFORMED. OVER THE COURSE OF THE TREATMENT, 20 MG OF IA TPA WAS GIVEN AT "VARIOUS STAGES AND IN VARIOUS LOCATIONS." ACCORDING TO THE PROCEDURAL REPORT, ONLY THROMBUS FROM THE CAVERNOUS AND SUPRACLINOID SEGMENTS OF THE ICA COULD BE RETRIEVED WITH THE PENUMBRA SYSTEM AND A V2.5 MERCI RETRIEVER WAS USED TO RETRIEVE CLOT FROM THE MCA. THE PROCEDURAL REPORT INDICATES THAT "SOME VASOSPASM WAS SEEN INVOLVING THE M1 AND SUPRACLINOID ICA." THIS WAS TREATED WITH NITROGLYCERIN AND SUBSEQUENTLY RESOLVED. AFTER ADJUDICATION WITH THE PI, DR. (B)(6), IT WAS DETERMINED THAT THIS VASOSPASM WAS OF "PROBABLE" RELATIONSHIP TO THE PENUMBRA SYSTEM. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00126, 3005168196-2011-00139 AND 3005168196-2011-00140.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention