BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2502518 · Received March 23, 2012

    Report

    Report Number
    3005168196-2012-00107
    Event Type
    Death
    Date Received
    March 23, 2012
    Date of Event
    February 19, 2012
    Report Date
    February 28, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: EMBOLI 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 MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE REPERFUSION CATHETER 054 WAS USED TO ASPIRATE CLOTS N THE C2 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). AFTER THE C2 WAS OPENED, ADDITIONAL EMBOLI CAUSED REOCCLUSION. A BALLOON PTA PROCEDURE WAS USED TO REOPEN THE C2 BUT IT OCCLUDED AGAIN. A STENT WAS PLACED WITH PTA AT THE C2 SEGMENT BUT STILL THE OCCLUSION REMAINED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. THE PHYSICIAN NOTED ATHEROSCLEROTIC PLAQUE AT THE SITE OF THE LESION WHICH CAUSED THE EMBOLI. HE WAS NOT SURE WHICH DEVICE CAUSED RUPTURE OF THE PLAQUE AND THE RELEASE OF DISTAL EMBOLI. INTRAVENOUS OZAGREL WAS ADMINISTERED TO THE PATIENT AFTER TREATMENT. THE PATIENT DIED ON (B)(6) 2012. THE PHYSICIAN COMMENTED THAT ADDITIONAL TREATMENTS COULD NOT HAVE PREVENTED THE REOCCLUSION. THE PATIENT WAS CONTRAINDICATED FOR T-PA; THEREFORE, IT WAS NOT ADMINISTERED; HOWEVER, IT WAS NOTED THAT IT MIGHT HAVE LEAD TO A DIFFERENCE IN THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY NRY PENUMBRA, INC. F23249

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O