BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA ULTRA

    MDR report key: 14954626 · Received July 8, 2022

    Report

    Report Number
    3004066202-2022-00003
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    November 23, 2021
    Report Date
    July 8, 2022
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATIONSHIP BETWEEN CEREBRAL HYPERPERFUSION SYNDROME AND THE IMMEDIATE CHANGE OF CEREBRAL BLOOD FLOW AFTER CAROTID ARTERY STENTING EVALUATED BY SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY NEURORADIOLOGY (2022) 64:1157¿1164. AGE: AVERAGE AGE. GENDER: MAJORITY GENDER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED AN ARTICLE DISCUSSING THE 'RELATIONSHIP BETWEEN CEREBRAL HYPERPERFUSION SYNDROME AND THE IMMEDIATE CHANGE OF CEREBRAL BLOOD FOW AFTER CAROTID ARTERY STENTING EVALUATED BY SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY' A RETROSPECTIVE CHART REVIEW WAS PERFORMED FOR 223 PATIENTS WITH CHRONIC EXTRACRANIAL CAROTID ARTERY STENOSIS TREATED WITH CAS AT A HOSPITAL BETWEEN MARCH 2010 AND MARCH 2020. FOR AT LEAST 7 DAYS BEFORE CAS, EACH PATIENT RECEIVED ORAL DUAL ANTIPLATELET TREATMENT OF ASPIRIN (100 MG/DAY), CLOPIDOGREL (75 MG/DAY), OR CILOSTAZOL (200 MG). UNDER LOCAL ANESTHESIA, ALL PROCEDURES WERE PERFORMED USING A FEMORAL APPROACH WITH AN 8-FT-LONG SHEATH. AT THE BEGINNING OF THE PROCEDURE, HEPARIN WAS GIVEN INTRAVENOUSLY TO ACHIEVE AN ACTIVATED CLOTTING TIME>250 S. THE 8-FT-GUIDING CATHETER WAS INTRODUCED INTO THE IPSILATERAL COMMON CAROTID ARTERY. DEPENDING ON THE NATURE OF THE LESION, THE OPERATORS SELECTED FROM FIVE TYPES OF EMBOLIC PROTECTION DEVICES: DISTAL BALLOON PROTECTION USING PERCUSURGE GUARDWIRE (MEDTRONIC AVE; N=112); DISTAL FLTER PROTECTION USING FILTERWIRE EZ (BOSTON SCIENTIFIC; N=90); PROXIMAL BALLOON PROTECTION USING OPTIMO (TOKAI MEDICAL PRODUCTS) AND DISTAL BALLOON PROTECTION USING PERCUSURGE GUARDWIRE (N=12); PROXIMAL BALLOON PROTECTION USING OPTIMO AND DISTAL FLTER PROTECTION USING FILTERWIRE EZ (N=5); OR PROXIMAL BALLOON PROTECTION USING MO. MA ULTRA (MEDTRONIC) AND DISTAL FLTER PROTECTION USING FILTERWIRE EZ (N=4). IN MOST CASES, A 3.0- OR 3.5-MM BALLOON CATHETER WAS USED TO PREDILATE THE STENOSIS. THREE TYPES OF STENTS WERE PLACED IN THE STENOTIC LESION: PRECISE (CORDIS; N=74); PROTEGE (MEDTRONIC; N=20); OR WALLSTENT (BOSTON SCIENTIFIC; N=129). POST-DILATION WAS PERFORMED WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON FOR RESIDUAL STENOSIS. WHEN A DISTAL BALLOON PROTECTION DEVICE WAS USED, AN ASPIRATION CATHETER WAS USED TO REMOVE DEBRIS FROM THE TREATED VESSEL BEFORE THE BALLOON WAS DEFLATED AND ANTEGRADE FLOW IN THE VESSEL WAS RESTORED. THE MEDIAN TOTAL OCCLUSION TIME WAS 9 MIN (8¿11 MIN). THE FINAL RESIDUAL STENOSIS RATE (%) WAS EVALUATED USING NASCET MEASUREMENT CRITERIA BY COMPLETE ANGIOGRAPHY. ALL PATIENTS RECEIVED MAINTENANCE ORAL ANTIPLATELET TREATMENT STARTING ON THE DAY AFTER THE PROCEDURE. POSTOPERATIVE MRI WAS PERFORMED WITHIN 3 DAYS AFTER CAS. A DIFFUSION-WEIGHTED IMAGING (DWI)-POSITIVE LESION WAS DEFINED AS A LESION WITH A HIGH INTENSITY IN THE HEMISPHERE IPSILATERAL TO THE TREATED CAROTID ARTERY STENOSIS TERRITORY. OF THE 223 PATIENTS, 3 WITH PACEMAKERS WERE EXCLUDED FROM ANALYSIS BECAUSE MRI WAS NOT PERFORMED. THEREFORE, POSTOPERATIVE DWI-POSITIVE LESIONS WERE EVALUATED IN 220 PATIENTS. AN INCREASE IN QUANTITATIVE CBF OCCURRED IN 111 (49.8%) PATIENTS AND A DECREASE OCCURRED IN 112 (50.2%). OF THE 5 PATIENTS WITH HP, 4 (80%) DEVELOPED CHS, WHEREAS NONE OF THE 218 PATIENTS WITHOUT HP HAD DEVELOPMENT OF CHS. OF 4 PATIENTS WITH CHS, CASE 1 EXPERIENCED HEADACHE 4 H AFTER CAS, WITH A 59.2% QUANTITATIVE INCREASE IN CBF, CASE 2 HAD EYE PAIN AND DETERIORATION OF CONSCIOUSNESS 2 H AFTER CAS, WITH A 53.7% INCREASE IN CBF, CASE 3 HAD DETERIORATION OF CONSCIOUSNESS WITH RESTLESSNESS 1 DAY AFTER CAS, WITH A 79.7% INCREASE IN CBF, AND CASE 4 EXPERIENCED HEADACHE AND CT SHOWED INTRACEREBRAL HEMORRHAGE 2 DAYS AFTER CAS, WITH A 73.0% INCREASE IN CBF. INTRAOPERATIVE HYPOTENSION AND BRADYCARDIA OCCURRED IN 102 (45.7%) AND 70 (31.4%) CASES, AND HYPOTENSION AND HYPERTENSION AT THE END OF CAS WERE PRESENT IN 27 (12.1%) AND 21 (9.4%) CASES, RESPECTIVELY. THE FINAL RESIDUAL STENOSIS RATE WAS 6.0% (0.0¿19.5%). OF 220 PATIENTS WHO UNDERWENT MRI, 20 (9.1%) HAD A POSTOPERATIVE DWI-POSITIVE LESION, AND 3 PATIENTS WITH PACEMAKERS DID NOT DEVELOP HP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986276 MO.MA ULTRA TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE INVATEC SPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male