BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 7422602 · Received April 11, 2018

    Report

    Report Number
    0002954917-2018-00036
    Event Type
    Death
    Date Received
    April 11, 2018
    Date of Event
    November 1, 2017
    Report Date
    June 5, 2018
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE PRODUCT WAS NOT RETURNED, THEREFORE PHYSICAL AND FUNCTIONAL TESTS COULD NOT BE PERFORMED. HOWEVER, ADVERSE EVENTS ASSOCIATED WITH THE USE OF COIL OR WITH THE ENDOVASCULAR PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO: INTRACRANIAL HEMORRHAGE, NEUROLOGICAL DEFICITS, DEATH ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 WEEK PRIOR PROCEDURE, THE PATIENT DEVELOPED CEREBRAL INFARCTION THAT WAS TREATED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH MRS OF 2. THE DAY FOLLOWING THE DISCHARGE, THE PATIENT WAS READMITTED WITH NEUROLOGICAL SYMPTOMS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 10). MAGNETIC RESONANCE ANGIOGRAPHY (MRA) SHOWED LEFT INTERNAL CAROTID ARTERY (ICA) AND LEFT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, AND DIFFUSION WEIGHTED IMAGING (MRI-DWI) SHOWED HIGH SIGNAL IN LEFT TEMPORAL LOBE (ASPECT 9). SINCE THERE WAS A CLINICAL-DWI MISMATCH, IT WAS DECIDED TO PERFORM THROMBECTOMY. BEFORE THROMBECTOMY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND CAROTID ARTERY STENTING WERE UNDERTAKEN SINCE LEFT ICA WAS COMPLETELY OCCLUDED FROM THE ORIGIN. THEN, THROMBECTOMY WITH A STENT RETRIEVER (SUBJECT DEVICE) WAS PERFORMED ON THE LEFT MCA AND TICI 2B WAS ACHIEVED. AFTER THE PROCEDURE, THE PATIENT'S CONDITION BECAME WORSE (NIHSS WAS 15), AND COMPUTERIZED TOMOGRAPHY (CT) SHOWED INTRACEREBRAL HEMORRHAGE (ICH) IN LEFT FRONTAL LOBE, INTRAVENTRICULAR HEMORRHAGE IN LATERAL VENTRICLE. THE PATIENT'S CONDITION BECAME MUCH WORSE AND THE PATIENT DIED 1 WEEK AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 WEEK PRIOR PROCEDURE, THE PATIENT DEVELOPED CEREBRAL INFARCTION THAT WAS TREATED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH MRS OF 2. THE DAY FOLLOWING THE DISCHARGE, THE PATIENT WAS READMITTED WITH NEUROLOGICAL SYMPTOMS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 10). MAGNETIC RESONANCE ANGIOGRAPHY (MRA) SHOWED LEFT INTERNAL CAROTID ARTERY (ICA) AND LEFT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, AND DIFFUSION WEIGHTED IMAGING (MRI-DWI) SHOWED HIGH SIGNAL IN LEFT TEMPORAL LOBE (ASPECT 9). SINCE THERE WAS A CLINICAL-DWI MISMATCH, IT WAS DECIDED TO PERFORM THROMBECTOMY. BEFORE THROMBECTOMY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND CAROTID ARTERY STENTING WERE UNDERTAKEN SINCE LEFT ICA WAS COMPLETELY OCCLUDED FROM THE ORIGIN. THEN, THROMBECTOMY WITH A STENT RETRIEVER (SUBJECT DEVICE) WAS PERFORMED ON THE LEFT MCA AND TICI 2B WAS ACHIEVED. AFTER THE PROCEDURE, THE PATIENT'S CONDITION BECAME WORSE (NIHSS WAS 15), AND COMPUTERIZED TOMOGRAPHY (CT) SHOWED INTRACEREBRAL HEMORRHAGE (ICH) IN LEFT FRONTAL LOBE, INTRAVENTRICULAR HEMORRHAGE IN LATERAL VENTRICLE. THE PATIENT'S CONDITION BECAME MUCH WORSE AND THE PATIENT DIED 1 WEEK AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263439 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O