BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 2040830 · Received March 31, 2011

    Report

    Report Number
    3005168196-2011-00125
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    November 14, 2010
    Report Date
    March 9, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE PENUMBRA SYSTEM INCLUDE ACUTE OCCLUSION, DEATH, INABILITY TO COMPLETELY REMOVE THROMBUS OR VESSEL DISSECTION AND ARE INCLUDED IN THE 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 HOSPITAL.

    Description of Event or Problem · 1

    THE LAST TIME THE PT WAS REPORTED IN A NORMAL STATE WAS AT 7:30 PM (B)(6) 2010 WHEN THE PT'S DAUGHTER SPOKE TO HER ON THE PHONE. ON THE MORNING OF (B)(6) 2010 THERE WAS NO RESPONSE TO PHONE CALLS OR AT THE DOOR. PT WAS FOUND ON THE FLOOR NON-VERBAL AND NOT MOVING RIGHT SIDE. REPORTEDLY (B)(6) WAS 15 WITH AN OCCLUSION IN THE LEFT MCA TRIFURCATION. NO TREATMENT WAS GIVEN BEFORE USE OF THE PENUMBRA SYSTEM. DURING A REVIEW OF THE CLINICAL REPORT, POST PROCEDURE DIAGNOSIS AFTER USE OF THE PENUMBRA SYSTEM WAS "COMPLETE REOCCLUSION OF LEFT DISTAL M1 AND DISSECTION AND CLOT FORMATION IN LEFT ICA." THIS EVENT WAS LISTED AS HAVING DEFINITE RELATIONSHIP TO THE STUDY DEVICE AND UNRELATED TO THE ANGIOGRAPHIC PROCEDURE. THE EVENT LED TO PT DEATH ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death