BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 2770541 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00349
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    February 8, 2011
    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: VASOSPASM 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)(4), 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 DEVICE LOT HAVE BEEN REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    AFTER STENT DEPLOYMENT, THERE WAS GOOD FLOW IN THE ICA, BUT THERE WAS STILL OCCLUSION OF THE INTRACRANIAL VESSEL AT THE ICA TERMINUS AND THE MCA. A PENUMBRA 041 WAS ADVANCED OVER THE SYNCHRO2 WIRE TO THE ICA AND THE MCA. THIS WAS ACTIVATED WITH SUCTION AND THE SEPARATOR FOR DISSOLUTION OF THIS THROMBUS. THERE WAS STILL SOME RESIDUAL THROMBUS IN THE M1 SEGMENT AND THE DISTAL M2. AGAIN, THE MICROCATHETER, PENUMBRA 041 WAS ADVANCED OVER A SYNCHRO-2 MICROWIRE TO THE MCA AND WAS USED. AT THAT POINT, THE CATHETER WAS PULLED BACKWARD AND RUN WAS PERFORMED THAT SHOWED GOOD RECANALIZATION OF THE MCA AND THE DISTAL MCA, WITH GOOD BLUSH IN THE CAPILLARY PHASE. THE CATHETER WAS TAKEN OUT AND THE RUN WAS PERFORMED FROM THE CONCENTRIC CATHETER THAT SHOWED AN ICA CERVICAL SPASM. THE VASOSPASM WAS CONSIDERED A SEVERE EVENT, POSSIBLY RELATED TO THE STUDY DEVICE, AND POSSIBLY RELATED TO THE ANGIOGRAPHIC PROCEDURE. THE OUTCOME WAS RESOLVED WITH REMEDIAL THERAPY. THE PATIENT RECEIVED 10MG OF VERAPAMIL IA, AND THE FURTHER RUN SHOWED THAT THERE WAS GOOD FLOW TO THE MCA AND DISTAL BRANCHES OF THE MCA. FURTHER RUN SHOWED NO FURTHER VASOSPASM. THERE WAS TIMI-3 FLOW IN THE MCA AND AT THE END OF THE PROCEDURE. PATIENT HAD LEUKOCYTOSIS (B)(6) 2011. THE EVENT WAS REPORTED ON THE (B)(4) ON (B)(6) 2012. THE EVENT WAS SEVERE, UNRELATED TO THE STUDY DEVICE, AND UNRELATED TO THE ANGIOGRAPHIC PROCEDURE. THE OUTCOME WAS RESOLVED WITH REMEDIAL THERAPY ON (B)(6) 2011. PATIENT PRESENTED WITH CARDIOMYOPATHY ON (B)(6) 2011. THE EVENT WAS REPORTED ON THE (B)(4) ON (B)(6) 2012. THE EVENT WAS OF MODERATE SEVERITY. THE COORDINATOR DID NOT FILL OUT ANY ADDITIONAL DETAILS OF THE EVENT. IT HAS BEEN QUERIED ON THE (B)(4). PENUMBRA'S CLINICAL DEPARTMENT BECAME AWARE OF THESE EVENTS ON (B)(4) 2012. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00348--350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 NRY NRY PENUMBRA, INC. F17176

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention