BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2770529 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00345
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 16, 2010
    Report Date
    May 31, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMOTOMA 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. AS THIS PATIENT WAS ENROLLED IN THE POST-MARKET STUDY, (B)(6), THE EVENT WAS NOT DISCOVERED UNTIL LATER DATA COLLECTION AND THE SPONSOR REVIEWED THE FINAL DATA ENTRY DISCREPANCIES DURING STUDY CLOSE OUT. FINAL CLARIFICATION OF THE EVENT AND RELATIONSHIP TO THE SYSTEM WAS EVALUATED AND THE RELATIONSHIP TO THE DEVICE REMAINS "POSSIBLE". THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT WAS ADMITTED TO ANOTHER HOSPITAL, (B)(6), DUE TO ST ELEVATION MI. AFTER UNDERGOING 3 CORONARY STENTS FOR MI PROCEDURE, PATIENT DEVELOPED NEUROLOGICAL DEFICIT WITH RIGHT SIDED WEAKNESS. PATIENT WAS THEN TRANSFERRED TO MFG ON THE SAME DATE FOR ENDOVASCULAR TREATMENT. PATIENT WAS IDENTIFIED HAVING STROKE WITH LEFT M1 OCCLUSION ((B)(6) OF 14), MILD APHASIA, DYSARTHRIA, AND RIGHT HEMIPLEGIA. PATIENT WAS TREATED BY ENDOVASCULAR OPTION WITH A PENUMBRA DEVICE (054, 041, 032) AND ACHIEVED A GOOD RECANALIZATION OF THE M1 SEGMENT AND SUPERIOR AND INFERIOR TRUNK WITH GOOD FLOW (TIMI=3 AND TICI=3) AND NO COMPLICATIONS. EVEN THOUGH THERE WAS STILL SOME RESIDUAL FILLING DEFECT AT THE INFERIOR TRUNK BRANCH, PATIENT WAS REPORTED AS WELL TOLERATED PROCEDURE AND IMPROVED AFTER PROCEDURE. ON (B)(6) 2010, PATIENT WAS IDENTIFIED HAVING PARENCHYMAL HEMATOMA. THIS EVENT WAS REPORTED AS MODERATE AND NOT SERIOUS WITH POSSIBLE RELATIONSHIP TO STUDY DEVICE AND POSSIBLE RELATIONSHIP WITH ANGIOGRAPHIC PROCEDURE. NO ACTION WAS TAKEN FOR THIS EVENT. THIS WAS RESOLVED ON (B)(6) 2010. THE EVENT WAS REPORTED BY SITE ON (B)(6) 2012. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00342--00345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F17190

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other