BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 2770505 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00352
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    March 7, 2011
    Report Date
    June 4, 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: HEMORRHAGE 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

    PETECHIAL HEMORRHAGE WAS SEEN IN A CT SCAN ON (B)(6) 2011, 3 DAYS POST PROCEDURE. THE EVENT WAS SEVERE, POSSIBLY RELATED TO THE STUDY DEVICE, AND POSSIBLY RELATED TO THE ANGIOGRAPHIC PROCEDURE. THE OUTCOME WAS RESOLVED ON (B)(6) 2011. THE PETECHIAL HEMORRHAGE WAS NEW IN COMPARISON TO THE PRIOR CT PERFUSION EXAM. FOLLOW-UP CT SCAN SHOWED NO PROGRESSION OF THE HEMORRHAGE. THERE WAS NO TREATMENT REQUIRED. IN A FOLLOWING SCAN ON (B)(6) 2011, THE PETECHIAL HEMORRHAGE WAS SEEN, BUT NO LARGE LOBE HEMATOMA. DIAGNOSTIC IMAGING REPORT INDICATED AN EVOLVING ISCHEMIC INFARCT IN THE LEFT MCA TERRITORY, (B)(6) 2011. THERE WAS PROGRESSION OF THE STROKE, (B)(6) 2011. THE EVENT WAS SEVERE, UNRELATED TO THE STUDY DEVICE, AND UNRELATED TO THE ANGIOGRAPHIC PROCEDURE. THE OUTCOME ENDED WITH THE DEATH OF THE PATIENT. PATIENT EXPIRED ON (B)(6) 2011, CAUSED BY RESPIRATORY ARREST SECONDARY TO CVA. PENUMBRA'S CLINICAL DEPARTMENT BECAME AWARE OF THESE EVENTS ON (B)(4) 2012. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00351.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 NRY NRY PENUMBRA, INC. F16049

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other