BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2040831 · Received March 31, 2011

    Report

    Report Number
    3005168196-2011-00124
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    October 3, 2010
    Report Date
    March 10, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VESSEL PERFORATION 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 PENUMBRA (B)(4) STUDY. THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A PENUMBRA SYSTEM REPERFUSION CATHETER 032 "TO ATTEMPT TO RESTORE FLOW IN THE ANTERIOR AND POSTERIOR DIVISION BRANCHES OF THE LEFT MIDDLE CEREBRAL ARTERY M2 BRANCHES, BUT THERE IS A PERFORATION INVOLVING THE REPERFUSION CATHETER AND FATHOM WIRE IN THE POSTERIOR DIVISION M2 BRANCH WHICH WAS INITIALLY OPENED BY THIS SYSTEM, BUT THEN REOCCLUDED. IMMEDIATE POST-CT SCAN SHOWED LEFT BASAL GANGLIA HEMORRHAGE AND DIFFUSE SUBARACHNOID HEMORRHAGE." THE PT DEVELOPED A LARGE HEMORRHAGE AND DIED. THE PHYSICIAN STATED THAT THE EVENT IS DEFINITELY RELATED TO THE PENUMBRA DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE HOSPITAL PROVIDED INFO THAT THE PT WAS DISCHARGED TO HOSPICE, AND THAT THE DATE OF DEATH IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death