BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA VELOCITY MICROCATHETER

    MDR report key: 2870233 · Received December 12, 2012

    Report

    Report Number
    3005168196-2012-00420
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VESSEL PERFORATION AND EMBOLI ARE KNOWN AND ANTICIPATED COMPLICATIONS ASSOCIATED WITH THESE TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THESE LOTS WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR TREATMENT OF ACUTE STROKE IN HER LEFT MCA ON (B)(6) 2012, AND ENROLLED IN THE SEPARATOR 3D TRIAL WITH RANDOMIZATION TO THE PENUMBRA SYSTEM ALONE. THE THROMBUS WAS INITIALLY ACCESSED WITH THE PENUMBRA 4MAX CATHETER OVER A VELOCITY AND SYNCHRO 2 MICROWIRE. WITH THE RESPECTIVE PENUMBRA SEPARATORS, ASPIRATION WAS PERFORMED WITH THE 4MAX AND THEN WITH THE 3MAX. AFTER THIS ASPIRATION, IT WAS NOTED THAT THERE WAS CONTRAST EXTRAVASATION IN THE M2 SEGMENT. AT THAT POINT, THE DECISION WAS MADE TO USE THE SOLITAIRE DEVICE AND THREE PASSES WERE ATTEMPTED IN THE MCA WITHOUT FULL RECANALIZATION. THE INVESTIGATORS THEN SWITCHED TO THE TREVO DEVICE AND PERFORMED THREE ADDITIONAL PASSES, RESTORING THE FLOW TO TICI 2A. TWO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. THE FIRST IS THAT THE 3MAX SEPARATOR PERFORATED THE VESSEL CREATING A SMALL SAH IN THE SYLVIAN FISSURE. THIS WAS FIRST REPORTED BY THE SITE ON (B)(6) 2012 BUT THE RELATIONSHIP TO THE DEVICE WAS NOT CONFIRMED UNTIL (B)(6) 2012 WHEN THE INVESTIGATOR REPORTED IS AS MILD AND DEFINITELY RELATED TO THE PROCEDURE AND THE PENUMBRA SYSTEM. THE EVENT RESOLVED WITHOUT TREATMENT. THE SECOND EVENT WAS THAT NEW DISTAL EMBOLI WAS CREATED IN THE ACA FOLLOWING THE PASS WITH THE SOLITAIRE DEVICE. THIS WAS REPORTED AS MODERATE IN SEVERITY, WITH "UNCERTAIN" RELATIONSHIP TO THE PENUMBRA SYSTEM AND "DEFINITE" RELATIONSHIP TO THE PROCEDURE. THIS WAS REPORTED ON (B)(6) 2012. MDRS 3005168196-2012-00419 THROUGH 3005168196-2012-00423 ARE ASSOCIATED WITH THE SAME PATIENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA VELOCITY MICROCATHETER DQY DQY PENUMBRA, INC. F28903

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other