BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 14935410 · Received July 6, 2022

    Report

    Report Number
    2029214-2022-01122
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    January 1, 2015
    Report Date
    July 6, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HYOUNG-GYU JANG, JUNG-SOO PARK, JONG-MYONG LEE, HYO-SUNG KWAK. INITIAL EXPERIENCE OF ACE68 REPERFUSION CATHETER IN PATIENTS WITH ACUTE ISCHEMIC STROKE RELATED TO INTERNAL CAROTID ARTERY OCCLUSION. JOURNAL OF KOREAN NEUROSURG SOC. 2019.0108. HTTPS://DOI.ORG/10.3340/JKNS.2019.0108.  REFER TO REGULATORY REP #: 2029214-2022-01121 FOR RELATED EVENT INFORMATION. A2 73 YEARS IS THE AVERAGE AGE OF THE PATIENTS WHO USED SOLITAIRE DEVICES IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HYOUNG-GYU JANG, JUNG-SOO PARK, JONG-MYONG LEE, HYO-SUNG KWAK. INITIAL EXPERIENCE OF ACE68 REPERFUSION CATHETER IN PATIENTS WITH ACUTE ISCHEMIC STROKE RELATED TO INTERNAL CAROTID ARTERY OCCLUSION. JOURNAL OF KOREAN NEUROSURG SOC. 2019.0108. HTTPS://DOI.ORG/10.3340/JKNS.2019.0108.   THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE EFFICACY OF THIS CATHETER IN COMPARISON TO THAT OF PREVIOUS PENUMBRA CATHETERS IN PATIENTS WITH ACUTE ISCHEMIC STROKE RELATED TO INTERNAL CAROTID ARTERY (ICA) OCCLUSION. THERE WERE 75 PATIENTS, 42 WERE FEMALE AND 33 WERE MALE. THE AVERAGE AGE WAS 73 YEARS.   ACE68 REPERFUSION CATHETER WAS USED IN 29 OF 75 ELIGIBLE PATIENTS (39%). THE PUNCTURE TO RECANALIZATION TIME WAS SIGNIFICANTLY SHORTER (26±18.2 MINUTES VS. 40±24.9 MINUTES, P=0.011) AND THE RATE OF SWITCH TO STENT-BASED RETRIEVAL WAS SIGNIFICANTLY LOWER (3% VS. 20%, P=0.046) IN ACE68 CATHETER GROUP. MOREOVER, ALTHOUGH NOT STATISTICALLY SIGNIFICANT, THE SUCCESSFUL RECANALIZATION RATE WAS HIGHER (83% VS. 76%, P=0.492) IN ACE68 CATHETER GROUP. FAVORABLE FUNCTIONAL OUTCOME WAS OBSERVED IN 48% OF PATIENTS TREATED WITH ACE68 REPERFUSION CATHETER AND IN 30% OF PATIENTS TREATED USING OTHER PENUMBRA SYSTEMS (P=0.120). BASELINE ALBERTA STROKE PROGRAM EARLY CT SCORES =8 (ODDS RATIO [OR], 9.74; 95% CONFIDENCE INTERVAL [CI], 1.72¿54.99; P=0.010) AND SUCCESSFUL RECANALIZATION (OR, 10.20; 95% CI, 1.13¿92.46; P=0.039) WERE INDEPENDENT PREDICTORS OF FAVORABLE OUTCOME. AFTER THE ICA OCCLUSION SITE WAS DEFINED BY ANGIOGRAPHY, A PENUMBRA ASPIRATION CATHETER WAS INTRODUCED TO THE FACE OF THE CLOT TRIAXIALLY OVER A REBAR 18 MICROCATHETER (EV3, IRVINE, CA, USA). IF RECANALIZATION WAS NOT ACHIEVED APPLYING THIS TECHNIQUE 3¿5 TIMES, A SOLITAIRE STENT RETRIEVAL SYSTEM (COVIDIEN, IRVINE, CA, USA) WAS USED.   THEFOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES RELATED TO THE MEDTRONIC PIPELINE WERE NOTED:  1. THROMBOLYSIS IN CEREBRAL INFARCTION   2. SYMPTOMATIC HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014130 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other