BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 SOFT EXT PTFE

    MDR report key: 3021216 · Received March 26, 2013

    Report

    Report Number
    0002954917-2013-00038
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    May 15, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, HEMORRHAGE, HEMATOMA AND VASOSPASM ARE NOTED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH SUCH PROCEDURES IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN DISPOSED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR A RIGHT MIDDLE CEREBRAL ARTERY (R-MCA) OCCULSION. TWO PASSES WERE MADE WITH THIS RETRIEVER. ANGIOPLASTY WAS PERFORMED. A VESSEL SPASM WAS CONFIRMED AFTER RETREIVAL, WHERE AN ANEURYSM DEVELOPED. A SUBARACHONOID HEMMORHAGE (SAH) WAS CONFIRMED POST PROCEDURE. THE SAH HAD DEVELOPED INTO A HEMATOMA AND WAS SURGICALLY REMOVED. EXTERNAL CEREBRAL DECOMPRESSION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR A RIGHT MIDDLE CEREBRAL ARTERY (R-MCA) OCCULSION. TWO PASSES WERE MADE WITH THIS RETRIEVER. ANGIOPLASTY WAS PERFORMED. A VESSEL SPASM WAS CONFIRMED AFTER RETREIVAL, WHERE AN ANEURYSM DEVELOPED. A SUBARACHONOID HEMMORHAGE (SAH) WAS CONFIRMED POST PROCEDURE. THE SAH HAD DEVELOPED INTO A HEMATOMA AND WAS SURGICALLY REMOVED. EXTERNAL CEREBRAL DECOMPRESSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124755 V 2.0 SOFT EXT PTFE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening