BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA ULTRA

    MDR report key: 12041586 · Received June 22, 2021

    Report

    Report Number
    3004066202-2021-00009
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    September 15, 2020
    Report Date
    June 22, 2021
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: CLINICAL TRIAL OF CAROTID ARTERY STENTING USING DUALLAYER CASPER STENT FOR CAROTID ENDARTERECTOMY IN PATIENTS AT HIGH AND NORMAL RISK IN THE JAPANESE POPULATION IMAMURA H, ET AL. J NEUROINTERVENT SURG 2021;13:524529. DOI:10.1136/NEURINTSURG-2020-016250 (HTTP://DX.DOI.ORG/10.1136/ NEURINTSURG-2020-016250). DATE OF EVENT: DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A CLINICAL TRIAL FOR GOVERNMENT APPROVAL OF A NON-MEDTRONIC DEVICE IN PATIENTS AT EITHER HIGH OR NORMAL RISK FOR CAROTID ENDARTERECTOMY. 163 PATIENTS WERE INCLUDED IN THE STUDY. MEDTRONICS SPIDER FX EMBOLIC PROTECTION DEVICE AND MO.MA ULTRA CEREBRAL PROTECTION DEVICE WERE USED 5.7% OF CASES EACH. MULTIPLE PROTECTION DEVICES WERE USED IN 19.3% OF PROCEDURES. CLINICAL EVENTS OF LEFT HEMIPARESIS IN ONE PATIENT WHICH OCCURRED IMMEDIATELY AFTER STENT DEPLOYMENT, AND THE RESPONSIBLE INFARCTION WAS REVEALED IN THE RIGHT FRONTAL AND OCCIPITAL LOBE, AND ONE PATIENT PRESENTED WITH LEFT HEMIPARESIS 1DAY AFTER CAS WHERE CAROTID ULTRASONOGRAPHY REVEALED PLAQUE PROTRUSION WITHIN THE STENT, REQUIRING ADDITIONAL STENTING WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY THE SAME DAY. THERE WERE NO REPORTS OF DEATH OR MI WITHIN 30 DAYS, AND NO IPSILATERAL STROKE WITHIN 1YEAR AFTER THE PROCEDURE. THE TLR RATE WAS 2.4%, AND ADDITIONAL TREATMENTS WERE PERFORMED 180365 DAYS AFTER STENT PLACEMENT IN TWO CASES AND 1 DAY AFTER IN ONE CASE. CEREBROVASCULAR EVENTS OCCURRED IN 7.2% OF CASES INCLUDING ISCHEMIC STROKE AND TIA IN 2 AND 8 CASES RESPECTIVELY. SEVERE STROKE RESULTING IN NEUROLOGICAL SYMPTOMS LASTING >7 DAYS AND DETERIORATION OF THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OCCURRED ON THE DAY OF THE PROCEDURE IN ONE CASE. MINOR STROKE, WHICH RESOLVED WITHIN 7 DAYS OR PRESENTED WITH A DETERIORATION IN NIHSS SCORE WAS ENCOUNTERED WITHIN 130 DAYS IN ONE CASE. NO INSTANCES OF IPSILATERAL STROKE WERE RECORDED BETWEEN 30 DAYS AND 1YEAR. TIAS OCCURRED AT ANY TIME, WITH 2, 3, AND 3 TIAS OCCURRING ON THE DAY OF CAS, WITHIN 130 DAYS, AND BETWEEN 30 DAYS AND 1YEAR, RESPECTIVELY. ONE PATIENT HAD CRANIAL NERVE PALSY, BUT THIS WAS A BILATERAL FACIAL PALSY UNRELATED TO THE STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936871 MO.MA ULTRA TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE INVATEC SPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention