BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACT CATHETER

    MDR report key: 19069369 · Received April 9, 2024

    Report

    Report Number
    2029214-2024-00604
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    May 2, 2023
    Report Date
    April 9, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K180715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID REACT-68 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID REACT-71 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID REACT-71 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A. G2: CITATION: AUTHORS: NARLOCH J, PIASECKI A, ZIECINA P, D¸EBIEC A, WIERZBICKI M, STASZEWSKI J AND PIASECKI P. IS ASPIRATION AN EFFECTIVE ACUTE STROKE TREATMENT IN OLDER ADULTS?. FRONTIERS IN NEUROLOGY 2023. DOI: 10.3389/FNEUR.2023.114953 A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    NARLOCH J, PIASECKI A, ZIECINA P, DEBIEC A, WIERZBICKI M, STASZEWSKI J AND PIASECKI P (2023) IS ASPIRATION AN EFFECTIVE ACUTE STROKE TREATMENT IN OLDER ADULTS? FRONT. NEUROL. 14:1149531. DOI: 10.3389/FNEUR.2023.114953 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH REACT 68 AND 71 CATHETERS. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF A DIRECT ASPIRATION FIRST-PASS TECHNIQUE IN INTERVENTIONAL STROKE TREATMENT FOR ELDERLY PATIENTS COMPARED WITH YOUNGER PATIENTS CONSECUTIVE PATIENTS WHO UNDERWENT ¿A DIRECT ASPIRATION FIRST-PASS TECHNIQUE¿ (ADAPT) AS THE FIRST CHOICE OF TREATMENT FOR THE TREATMENT OF STROKE DUE TO A LARGE VESSEL OCCLUSION BETWEEN JANUARY 2016 AND AUGUST 2021 AT A COMPREHENSIVE STROKE CENTER WERE INCLUDED IN THE PRESENT STUDY. A TOTAL OF 162 PATIENTS (92 WOMEN AND 70 MEN, AGED BETWEEN 35 AND 94 YEARS +/¿ 12.4 YEARS) WERE INCLUDED. TO CONFIRM THE CEREBRAL LARGE-VESSEL OCCLUSION (LVO), AN IMPRESS DIAGNOSTIC PERIPHERAL CATHETER (MERIT MEDICAL) WAS PLACED IN AN 8F RADIFOCUS SUPER ARROW-FLEX SHEATH INTRODUCER (ARROW INTERNATIONAL INC.). THE DIAGNOSTIC CATHETER WAS EXCHANGED FOR A GUIDING CATHETER, SUCH AS NEURON MAX (PENUMBRA, INC., ALAMEDA, CA, USA) OR FUBUKI (TERUMO-MICROVENTION). THE FOLLOWING ASPIRATION CATHETERS WERE USED IN THIS STUDY: THE REACT 68 AND REACT 71 (MEDTRONIC); SOFIA AND SOFIA PLUS (TERUMO-MICROVENTION); AXS CATALYST 5, 6, AND 7 (STRYKER); OR ACE 68, JET7 (PENUMBRA INC.). A MICROCATHETER HEADWAY 0.021¿ (TERUMO-MICROVENTION) WITH 0.014¿ MICROWIRE TRAXCESS (TERUMO, TOKYO, JAPAN) WAS USED TO REACH THE OCCLUSION SITE. ASPIRATION PASSES WERE PERFORMED USING ADAPT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE REACT CATHETERS THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: - 3 HAD COMPLICATIONS IN THE 60 GROUP, 17 IN THE =60 GROUP, 5 IN THE 65 GROUP, 15 IN THE =65 GROUP, 13 IN THE 80 GROUP, AND 7 IN THE =80 GROUP. - 7 HAD HEMORRHAGE AT 24 HOURS IN THE 60 GROUP, 34 IN THE =60 GROUP, 15 IN THE 65 GROUP, 27 IN THE =65 GROUP, 31 IN THE 80 GROUP, AND 11 IN THE =80 GROUP. - 2 HAD SAH IN THE 60 GROUP, 8 IN THE =60 GROUP, 2 IN THE 65 GROUP, 8 IN THE =65 GROUP, 4 IN THE 80 GROUP, AND 6 IN THE =80 GROUP. - 1 HAD ICH IN THE 60 GROUP, 1 IN THE =60 GROUP, 2 IN THE 65 GROUP, 0 IN THE =65 GROUP, 2 IN THE 80 GROUP, AND 0 IN THE =80 GROUP. - 1 HAD VASOSPASM IN THE 60 GROUP, 3 IN THE =60 GROUP, 1 IN THE 65 GROUP, 3 IN THE =65 GROUP, 4 IN THE 80 GROUP, AND 0 IN THE =80 GROUP. - 0 HAD EMBOLIZATION IN A NEW TERRITORY IN THE 60 GROUP, 11 IN THE =60 GROUP, 3 IN THE 65 GROUP, 8 IN THE =65 GROUP, 9 IN THE 80 GROUP, AND 2 IN THE =80 GROUP. - 0 HAD DISSECTION IN THE 60 GROUP, 4 IN THE =60 GROUP, 0 IN THE 65 GROUP, 4 IN THE =65 GROUP, 3 IN THE 80 GROUP, AND 1 IN THE =80 GROUP. - 7 DIDN'T HAVE MTICI 2B-3 IN THE 60 GROUP, 50 IN THE =60 GROUP, 15 IN THE 65 GROUP, 42 IN THE =65 GROUP, 42 IN THE 80 GROUP, AND 15 IN THE =80 GROUP. -MRS WAS 0 AT DISCHARGE FOR 4 IN THE 60 GROUP, 7 IN THE =60 GROUP, 5 IN THE 65 GROUP, 6 IN THE =65 GROUP, 10 IN THE 80 GROUP, AND 1IN THE =80 GROUP -MRS WAS 1 AT DISCHARGE FOR 5 IN THE 60 GROUP, 14 IN THE =60 GROUP, 6 IN THE 65 GROUP, 13 IN THE =65 GROUP, 15 IN THE 80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 2 AT DISCHARGE FOR 4 IN THE 60 GROUP, 17 IN THE =60 GROUP, 9 IN THE 65 GROUP, 12 IN THE =65 GROUP, 19 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 3 AT DISCHARGE FOR 3 IN THE 60 GROUP, 10 IN THE =60 GROUP, 6 IN THE 65 GROUP, 7 IN THE =65 GROUP, 12 IN THE 80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 4 AT DISCHARGE FOR 1 IN THE 60 GROUP, 11 IN THE =60 GROUP, 2 IN THE 65 GROUP, 10 IN THE =65 GROUP, 8 IN THE 80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 5 AT DISCHARGE FOR 7 IN THE 60 GROUP, 38 IN THE =60 GROUP, 14 IN THE 65 GROUP, 31 IN THE =65 GROUP, 33 IN THE 80 GROUP, AND 12 IN THE =80 GROUP -MRS WAS 6 AT DISCHARGE FOR 5 IN THE 60 GROUP, 30 IN THE =60 GROUP, 9 IN THE 65 GROUP, 26 IN THE =65 GROUP, 26 IN THE 80 GROUP, AND 9 IN THE =80 GROUP -MRS WAS 0 AT 30 DAYS FOR 3 IN THE 60 GROUP, 8 IN THE =60 GROUP, 4 IN THE 65 GROUP, 7 IN THE =65 GROUP, 9 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 1 AT 30 DAYS FOR 6 IN THE 60 GROUP, 9 IN THE =60 GROUP, 6 IN THE 65 GROUP, 9 IN THE =65 GROUP, 14 IN THE 80 GROUP, AND 1IN THE =80 GROUP -MRS WAS 2 AT 30 DAYS FOR 3 IN THE 60 GROUP, 16 IN THE =60 GROUP, 7 IN THE 65 GROUP, 12 IN THE =65 GROUP, 17 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 3 AT 30 DAYS FOR 3 IN THE 60 GROUP, 18 IN THE =60 GROUP, 8 IN THE 65 GROUP, 13 IN THE =65 GROUP, 19 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 4 AT 30 DAYS FOR 0 IN THE 60 GROUP, 12 IN THE =60 GROUP, 2 IN THE 65 GROUP, 10 IN THE =65 GROUP, 8 IN THE 80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 5 AT 30 DAYS FOR 8 IN THE 60 GROUP, 33 IN THE =60 GROUP, 15 IN THE 65 GROUP, 26 IN THE =65 GROUP, 31 IN THE 80 GROUP, AND 10 IN THE =80 GROUP -MRS WAS 6 AT 30 DAYS FOR 5 IN THE 60 GROUP, 24 IN THE =60 GROUP, 7 IN THE 65 GROUP, 22 IN THE =65 GROUP, 21 IN THE 80 GROUP, AND 8 IN THE =80 GROUP -MRS WAS 0 AT 90 DAYS FOR 1 IN THE 60 GROUP, 5 IN THE =60 GROUP, 1 IN THE 65 GROUP, 5 IN THE =65 GROUP, 4 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 1 AT 90 DAYS FOR 5 IN THE 60 GROUP, 9 IN THE =60 GROUP, 6 IN THE 65 GROUP, 8 IN THE =65 GROUP, 14 IN THE 80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 2 AT 90 DAYS FOR 5 IN THE 60 GROUP, 17 IN THE =60 GROUP, 10 IN THE 65 GROUP, 12 IN THE =65 GROUP, 19 IN THE 80 GROUP, AND 3 IN THE =80 GROUP -MRS WAS 3 AT 90 DAYS FOR 0 IN THE 60 GROUP, 11 IN THE =60 GROUP, 2 IN THE 65 GROUP, 9 IN THE =65 GROUP, 9 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 4 AT 90 DAYS FOR 2 IN THE 60 GROUP, 12 IN THE =60 GROUP, 5 IN THE 65 GROUP, 9 IN THE =65 GROUP, 13 IN THE 80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 5 AT 90 DAYS FOR 3 IN THE 60 GROUP, 11 IN THE =60 GROUP, 6 IN THE 65 GROUP, 8 IN THE =65 GROUP, 12 IN THE 80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 6 AT 90 DAYS FOR 1 IN THE 60 GROUP, 18 IN THE =60 GROUP, 2 IN THE 65 GROUP, 17 IN THE =65 GROUP, 10 IN THE 80 GROUP, AND 9 IN THE =80 GROUP -MRS WAS 0 AT 12 MONTHS FOR 1 IN THE 60 GROUP, 1 IN THE =60 GROUP, 1 IN THE 65 GROUP, 1 IN THE =65 GROUP, 2 IN THE 80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 1 AT 12 MONTHS FOR 6 IN THE 60 GROUP, 6 IN THE =60 GROUP, 6 IN THE 65 GROUP, 6 IN THE =65 GROUP, 12 IN THE 80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 2 AT 12 MONTHS FOR 0 IN THE 60 GROUP, 10 IN THE =60 GROUP, 5 IN THE 65 GROUP, 5 IN THE =65 GROUP, 9 IN THE 80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 3 AT 12 MONTHS FOR 2 IN THE 60 GROUP, 7 IN THE =60 GROUP, 4 IN THE 65 GROUP, 5 IN THE =65 GROUP, 8 IN THE 80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 4 AT 12 MONTHS FOR 0 IN THE 60 GROUP, 4 IN THE =60 GROUP, 1 IN THE 65 GROUP, 3 IN THE =65 GROUP, 3 IN THE 80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 5 AT 12 MONTHS FOR 0 IN THE 60 GROUP, 1 IN THE =60 GROUP, 0 IN THE 65 GROUP, 1 IN THE =65 GROUP, 1 IN THE 80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 6 AT 12 MONTHS FOR 1 IN THE 60 GROUP, 15 IN THE =60 GROUP, 3 IN THE 65 GROUP, 13 IN THE =65 GROUP, 9 IN THE 80 GROUP, AND 7 IN THE =80 GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512569 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-68 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| S SEE H11...