BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 032

    MDR report key: 2023318 · Received February 15, 2011

    Report

    Report Number
    3005168196-2011-00114
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    September 4, 2010
    Report Date
    February 18, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: EMBOLI ARE KNOWN AND ANTICIPATED COMPLICATIONS 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 INFORMATION IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A (B)(6) STUDY. THE INFORMATION AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, WHILE AT WORK, PT EXPERIENCED SOME SLURRING OF SPEECH. BY THE TIME HE RETURNED HOME FOR DINNER AT 6:30PM, HE WAS BACK TO NORMAL AND WENT TO THE BED AT 9PM. AT 4:00AM ON (B)(6) 2010, WIFE HEARD HIM FALL IN THE BATHROOM AND FOUND HIM TO HAVE LEFT SIDED WEAKNESS. PT PRESENTED TO (B)(6) HOSPITAL AT 6:35 AM WITH A BASELINE NIHSS OF 15 AND OCCLUSION OF THE RIGHT M1. DURING THE PROCEDURE THE PENUMBRA SYSTEM REPERFUSION CATHETER 054 WAS USED COAXIALLY WITH THE PENUMBRA SYSTEM REPERFUSION CATHETER 032 TO PERFORM MECHANICAL THROMBOLYSIS ON THE CLOT ALONG WITH 6MG IA TPA. FOLLOWING ANGIOGRAPHY, THE PENUMBRA SYSTEM 041 WAS USED TO PERFORM SIGNIFICANT THROMBOLYSIS IN THE MCA. A F/U ANGIOGRAM SHOWED RECANALIZATION OF THE DISTAL M1; HOWEVER, THERE IS NOW A NEW A3 SEGMENT EMBOLUS THAT WAS NOT NOTED ON A PREVIOUS RUN. THIS NOVEL OCCLUSION WAS TREATED WITH THE PENUMBRA SYSTEM 026 IN ADDITION TO 6MG IA TPA. F/U ANGIOGRAPHY SHOWED TICI 2A RECANALIZATION OF THE ACA. HOWEVER, IT IS NOW SHOWN THAT THE MCA WAS OCCLUDED AGAIN. AT THIS POINT THE PROCEDURE WAS STOPPED AS IT WAS FELT THAT FURTHER ATTEMPTS TO RECANALIZE WOULD LIKE TO PUT THE PT AT RISK FOR FURTHER THROMBOEMBOLIC EVENTS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00115.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other