BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 11684512 · Received April 19, 2021

    Report

    Report Number
    2029214-2021-00448
    Event Type
    Death
    Date Received
    April 19, 2021
    Date of Event
    December 28, 2020
    Report Date
    April 19, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K180715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GROSS, BRADLEY A; HUDSON, JOSEPH S; TONETTI, DANIEL A; DESAI, SHASHVAT M; LANG, MICHAEL J; JADHAV, ASHUTOSH P; JANKOWITZ, BRIAN T; JOVIN, TUDOR G. NEUROSURGERY , APR2021, VOL. 88 ISSUE 4, P758-762, 5P. DOI:10.1093/NEUROS/NYAA498. AGE OR DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    GROSS, BRADLEY A; HUDSON, JOSEPH S; TONETTI, DANIEL A; DESAI, SHASHVAT M; LANG, MICHAEL J; JADHAV, ASHUTOSH P; JANKOWITZ, BRIAN T; JOVIN, TUDOR G. NEUROSURGERY , APR2021, VOL. 88 ISSUE 4, P758-762, 5P. DOI:10.1093/NEUROS/NYAA498 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ENDOVASCULAR THROMBECTOMY PROCEDURES UTILIZING A REACT 71 ASPIRATION CATHETER. THE PURPOSE OF THIS ARTICLE WAS TO REVIEW AN INSTITUTIONAL EXPERIENCE OVER 150 THROMBECTOMY CASES WITH THE NEW REACT 71 CATHETER WITH A COMPARISON TO OUR PREVIOUSLY MOST COMMONLY UTILIZED 0.068-INCH ASPIRATION CATHETER TO ELUCIDATE IF ANY SIGNIFICANT DIFFERENCES IN PASSES, REPERFUSION, OR CLINICAL OUTCOME ARE APPARENT. THE AUTHORS REVIEWED 150 CASES: THE AVERAGE AGE WAS 71 YEARS, 68 WERE FEMALE AND 82 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE REACT 71 CATHETER. MEAN PRESENTING NIHSS WAS 18, AND CT ASPECTS WAS 9. A TOTAL OF 27% OF PATIENTS RECEIVED TPA. A TOTAL OF 81% PERCENT OF PATIENTS HAD A HISTORY OF HYPERTENSION, 23% DIABETES, 35% ATRIAL FIBRILLATION, AND 33% WERE ACTIVE SMOKERS. FINAL SUCCESSFUL REPERFUSION (THROMBOLYSIS IN CEREBRAL INFARCTION [TICI] 2B-3) WAS ACHIEVED IN 95% OF CASES OVERALL. NINETY-DAY FOLLOW-UP MODIFIED RANKIN SCALE (MRS) WAS AVAILABLE FOR 135 PATIENTS (90%): GOOD OUTCOME (MRS 0-2) WAS SEEN. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. 40 PATIENTS WERE DECEASED BY THE 90 DAY FOLLOW UP. REFER TO MANUFACTURER REPORT 2029214-2021-00447 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EV ENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584464 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-68

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death