BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2010582 · Received March 1, 2011

    Report

    Report Number
    3005168196-2011-00066
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    November 23, 2010
    Report Date
    February 9, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    PT PRESENTED TO THE HOSPITAL WITH SYMPTOMS CONSISTENT WITH ACUTE ISCHEMIC STROKE AND A MRS OF 5. DURING THE PROCEDURE, A DISSECTION AND PSEUDOANEURYSM WAS NOTED IN THE LEFT MCA. ACCORDING TO THE TREATING PHYSICIAN, DR. (B)(6), IT IS UNCLEAR WHETHER THE CAUSATION FOR THE STROKE WAS A DISSECTION WITH OCCLUSION OR IF THE DISSECTION OCCURRED AS A RESULT OF THE PENUMBRA SYSTEM OR THE ANGIOGRAPHIC PROCEDURE. BECAUSE OF THIS, THE RELATIONSHIP TO THE STUDY DEVICE WAS DEEMED TO BE "UNCERTAIN". AN INTRACRANIAL STENT WAS PLACED TO ADDRESS THE DISSECTION AND MINIMIZE THE CHANCE OF HEMORRHAGE FROM A PSEUDOANEURYSM AS WELL AS RESTORE LUMINAL DIAMETER. FOLLOW UP INFO FROM THE HOSPITAL STATES THAT THE PT PASSED AWAY DUE TO "PULMONARY VASCULAR DECLINE" ON (B)(6) 2010. THE PT'S DEATH WAS DEEMED "UNRELATED" TO BOTH THE PENUMBRA SYSTEM OR ANGIOGRAPHIC PROCEDURE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00067 AND MDR 3005168196-2011-00100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA INC. F13607

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention