BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 10449527 · Received August 25, 2020

    Report

    Report Number
    2029214-2020-00834
    Event Type
    Death
    Date Received
    August 25, 2020
    Date of Event
    February 1, 2019
    Report Date
    August 25, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ASHUTOSH P. JADHAV, OSAMA O. ZAIDAT, DAVID S. LIEBESKIND, DILEEP R. YAVAGAL, DIOGO C. HAUSSEN, FRANK R. HELLINGER JR, REZA JAHAN, MOUHAMMAD A. JUMAA, VIKTOR SZEDER, RAUL G. NOGUEIRA, MD, AND TUDOR G. JOVIN. EMERGENT MANAGEMENT OF TANDEM LESIONS IN ACUTE ISCHEMIC STROKE. STROKE 2 (2019). DOI: 10.1161/STROKEAHA.118.021893. BACKGROUND AND PURPOSE¿ALTHOUGH INTRACRANIAL THROMBECTOMY REPRESENTS THE STANDARD TREATMENT APPROACH FOR ANTERIOR CIRCULATION TANDEM OCCLUSIONS, WHETHER THE EXTRACRANIAL LESION REQUIRES ACUTE STENTING REMAINS UNCLEAR. OUR AIM WAS TO INVESTIGATE DIFFERENCES IN CLINICAL AND PROCEDURAL OUTCOMES RELATED TO STENTING EXTRACRANIAL LESIONS IN A REGISTRY OF PATIENTS UNDERGOING THROMBECTOMY FOR ACUTE STROKE. METHODS¿DATA WERE ANALYZED FROM THE STRATIS REGISTRY (SYSTEMATIC EVALUATION OF PATIENTS TREATED WITH NEUROTHROMBECTOMY DEVICES FOR ACUTE ISCHEMIC STROKE)¿A PROSPECTIVE, NONRANDOMIZED STUDY OF PATIENTS UNDERGOING NEUROTHROMBECTOMY WITH THE SOLITAIRE DEVICE. A TOTAL OF 984 PATIENTS TREATED AT 55 SITES WERE ANALYZED. UNIVARIATE AND MULTIVARIABLE LOGISTIC REGRESSION WAS USED TO ASSESS RELATIONSHIP BETWEEN OUTCOME AND PROCEDURAL TECHNIQUE. RESULTS¿OF 147 (14.9%) PATIENTS WITH TANDEM LESIONS TREATED, STENTING OF THE EXTRACRANIAL LESION DURING THROMBECTOMY WAS PERFORMED IN 80 PATIENTS AND WITHHELD IN 67 PATIENTS. THERE WERE NO DIFFERENCES BETWEEN GROUPS WITH RESPECT TO AGE, ASPECTS (ALBERTA STROKE PROGRAM EARLY CT SCORE), OR INTRAVENOUS-TPA (TISSUE-TYPE PLASMINOGEN ACTIVATOR) USE. HOWEVER, THE PATIENTS IN THE STENTING GROUP HAD LOWER BASELINE NATIONALINSTITUTES OF HEALTH STROKE SCALE (16 VERSUS 17.9; P=0.07), SHORTER ONSET TO ARTERIAL PUNCTURE TIME (133.6 VERSUS 163.4 MINUTES; P=0.04), AND LOWER RATES OF ATRIAL FIBRILLATION (6.3% VERSUS 25.4%) AS COMPARED TO THE NONSTENTING GROUP. GOOD OUTCOMES (MODIFIED RANKIN SCALE, 0¿2 AT 90 DAYS) WERE HIGHER IN THE STENTING GROUP (68.5% VERSUS 42.2%; P=0.003) WITH NO DIFFERENCE IN MORTALITY OR SYMPTOMATIC HEMORRHAGE. AFTER ADJUSTMENT FOR COVARIATES, STENTING CONTINUED TO BE ASSOCIATED WITH SUPERIOR OUTCOMES. CONCLUSIONS¿ACUTE STENTING OF AN EXTRACRANIAL CAROTID STENOSIS DURING NEUROTHROMBECTOMY CAN BE ACHIEVED WITH EQUAL SAFETY COMPARED WITH NO STENTING. CAROTID STENTING IN THE ACUTE PHASE MAY LEAD TO BETTER OUTCOMES; THIS SHOULD IDEALLY BE CONFIRMED BY RANDOMIZED TRIALS. REPORTED EVENTS. - 7 CASES WITH NO ACUTE STENT PLACEMENT, 6 CASES WITH ANGIOPLASTY ONLY (ANGIOPLASTY ONLY IS A SUBSET OF THE NO-STENT GROUP THAT UNDERWENT ANGIOPLASTY ALONE WITHOUT ACUTE STENT PLACEMENT), AND 9 CASES WITH ACUTE STENT PLACEMENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915646 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death