BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 2770433 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00320
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    July 8, 2010
    Report Date
    June 17, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: ADDITIONAL STROKE AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENTS WERE ANTICIPATED PROCEDURAL COMPLICATIONS. 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 EVENTS AND RELATIONSHIP TO THE SYSTEM WAS EVALUATED AND THE RELATIONSHIP TO THE DEVICE REMAINS "POSSIBLE". EVAL SUMMARY: DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    INFORMATION PROVIDED AS OF (B)(6) 2010: (B)(6) (B)(4) UNDERWENT A CARDIAC CATHETERIZATION AND STENT PLACEMENT ON (B)(6) 2010. STROKE SYMPTOMS BECAME APPARENT THE FOLLOWING DAY, AND THE PATIENT WAS SHOWN TO HAVE A MID-BASILAR OCCLUSION. MECHANICAL ASPIRATION WAS PERFORMED WITH THE PENUMBRA SYSTEM, THROUGH UNFORTUNATELY THE PATIENT DID NOT FARE WELL POST PROCEDURE. FOUR SERIOUS ADVERSE EVENTS WERE REPORTED FOR THIS PATIENT, TWO OF WHICH WERE POSSIBLY RELATED TO THE PENUMBRA SYSTEM. INCREASING OBSTRUCTIVE HYDROCEPHALUS OCCURRED ON (B)(6), 2010, AND RESOLVED ON (B)(6), 2010. THERE WAS NO RELATIONSHIP BETWEEN THIS EVENT AND THE PENUMBRA SYSTEM. DESPITE REVASCULARIZATION ATTEMPTS, A POSTERIOR FOSSA INFARCTION OF THE CEREBELLUM WAS OBSERVED ON (B)(6) 2010. HOWEVER, SIGNIFICANT IMPROVEMENT WAS SEEN ON A POST PROCEDURAL CT CONDUCTED ON (B)(6) 2010. THERE WAS NO RELATIONSHIP BETWEEN THE INFARCTION AND THE PENUMBRA SYSTEM. A BRAIN STEM INFARCTION WHICH BEGAN ON (B)(6) 2010 WAS REPORTED AS BEING POSSIBLY RELATED TO EITHER THE PENUMBRA SYSTEM OR THE ANGIOGRAPHIC PROCEDURE. LAST, A SUBARACHNOID HEMORRHAGE THAT BEGAN ON (B)(6) 2010, AND RESOLVED ON (B)(6) 2010 WAS ALSO REPORTED AS BEING POSSIBLY RELATED TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE. ALL FOUR EVENTS WERE RATED AS SEVERE BY THE PHYSICIAN. ADDITIONAL DATA CONCERNING THE WELL-BEING OF THIS PATIENT HAS NOT YET BEEN PROVIDED BY THE SITE COORDINATOR THOUGH IS BEING SOUGHT BY PENUMBRA. ADDITIONALLY, WE ARE QUERYING THESE EVENTS TO OBTAIN A CLEARLY PICTURE AS TO HOW THEY WERE RELATED TO THE PENUMBRA SYSTEM. A SUBSEQUENT EMAIL DATED (B)(6) 2010 FROM THE PHYSICIAN EXPLAINED THAT THE POSTERIOR BRAIN STEM INFARCT WAS NOT RELATED TO THE PENUMBRA SYSTEM. THE SAH WAS STILL POSSIBLY RELATED. DURING REVIEW OF THE CLINICAL (B)(4) IN (B)(6) 2012, IT WAS REALIZED THAT THE PATIENT HAD BEEN EXCLUDED FROM THE STUDY DUE TO POSTERIOR LOCATION OF STROKE AND THE PATIENT'S ADVERSE EVENTS WERE NOT ADJUDICATED UNTIL STUDY CLOSE OUT IN (B)(6) 2012. THE PATIENT'S SAH WAS STILL DETERMINED TO BE POSSIBLY RELATED TO THE PENUMBRA SYSTEM. A NEW FORM WAS SUBMITTED FOR THIS REMAINING EVENT ON (B)(6) 2012. THIS MDR COMBINES BOTH REPORTS. MDRS 3005168196-2012-00318--00323 ARE RELATED TO THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other