BEUDAMED
    FDA Adverse Event Death Summary report: N

    8F BGC 95CM

    MDR report key: 2966420 · Received February 18, 2013

    Report

    Report Number
    0002954917-2013-00014
    Event Type
    Death
    Date Received
    February 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 22, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT OUTCOME OF VESSEL DISSECTION AND DEATH ARE NOTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR AN M2 OCCLUSION IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA). DURING DEPLOYMENT AND RETRIEVAL, THE PATIENT GOT UP AND THE BGC DEVICE MOVED AND CAUSED A DISSECTION AT THE LEFT INTERNAL CAROTID ARTERY (ICA). NO MEDICAL INTERVENTION WAS PERFORMED AS THE ANGIOGRAPHY HAD REVEALED CROSS FLOWS AT CONTRALATERAL ICA AND THE VERTEBRAL ARTERY. SYSTEMIC HEPARINIZATION HAD BEEN STARTED 24 HOURS POST PROCEDURE, BUT ISCHEMIA OF THE LEFT-MCA OCCURRED; 31.8 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS INTRAVENOUSLY ADMINISTERED TO THE PATIENT. THE PATIENT DIED EIGHT DAYS POST PROCEDURE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR AN M2 OCCLUSION IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA). DURING DEPLOYMENT AND RETRIEVAL, THE PATIENT GOT UP AND THE BGC DEVICE MOVED AND CAUSED A DISSECTION AT THE LEFT INTERNAL CAROTID ARTERY (ICA). NO MEDICAL INTERVENTION WAS PERFORMED AS THE ANGIOGRAPHY HAD REVEALED CROSS FLOWS AT CONTRALATERAL ICA AND THE VERTEBRAL ARTERY. SYSTEMIC HEPARINIZATION HAD BEEN STARTED 24 HOURS POST PROCEDURE, BUT ISCHEMIA OF THE LEFT-MCA OCCURRED; 31.8 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS INTRAVENOUSLY ADMINISTERED TO THE PATIENT. THE PATIENT DIED EIGHT DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70318 8F BGC 95CM CATHETER, PERCUTANEOUS DQY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death