BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 16743684 · Received April 14, 2023

    Report

    Report Number
    2029214-2023-00638
    Event Type
    Death
    Date Received
    April 14, 2023
    Date of Event
    February 1, 2017
    Report Date
    April 14, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K182097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO REGULATORY REP #: 2029214-2023-00635 FOR RELATED EVENT INFORMATION. BARRANCO-PONS R, CAAMANO I, GUILLEN A, CHIRIFE O, QUESADA H, CARDONA P. TRANSRADIAL VERSUS TRANSFEMORAL ACCESS FOR ACUTE STROKE ENDOVASCULAR THROMBECTOMY: A 4-YEAR EXPERIENCE IN A HIGH-VOLUME CENTER. NEURORADIOLOGY (2022) 64:999¿1009. DOI: 10.1007/S00234-021-02850-4. A2 73 YEARS IS THE AVERAGE AGE OF THE PATIENTS WHO PARTICIPATED IN THE STUDY. A3 MALE IS THE MAJORITY OF THE PARTICIPANTS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PURPOSE OF THE ARTICLE WAS TO COMPARE CLINICAL OUTCOMES AND SAFETY OF TRANSRADIAL (TRA) VERSUS TRANSFEMORAL ACCESS (TFA) FOR ENDOVASCULAR MECHANICAL THROMBECTOMY IN ACUTE STROKE PATIENTS.   BETWEEN FEBRUARY 2017 AND FEBRUARY 2021, A RETROSPECTIVE ANALYSIS OF 832 CONSECUTIVE PATIENTS WITH ACUTE STROKE UNDERGOING INTERVENTIONAL THROMBECTOMY USING TRA (N=64) OR TFA (N=768) WAS PERFORMED. DIRECT TFA FAILURES OCCURRED IN 36 PATIENTS, 18 OF WHICH UNDERWENT CROSSOVER TFA TO TRA, WHILE DIRECT TRA FAILURES OCCURRED IN 2 PATIENTS HAVING BOTH CROSSOVERS TO TFA. SUCCESSFUL CATHETERIZATION WAS ACHIEVED IN 96.8% (62/64) AND 95.3% (732/768) OF PATIENTS UNDERGOING DIRECT TRA AND DIRECT TFA, RESPECTIVELY, WITHOUT SIGNIFICANT DIFFERENCES. THE MEDIAN (IQR) CATHETERIZATION TIME WAS 10 (8¿16) MIN IN THE DIRECT TRA GROUP AND 15 (10¿20) IN THE DIRECT TFA GROUP. THIS DIFFERENCE WAS ALSO SIGNIFICANT IN THE SUBGROUP OF ANTERIOR CIRCULATION STROKES AND IN PATIENTS YOUNGER AND OLDER THAN 80 YEARS OF AGE. THE MAJORITY OF PROCEDURES YIELDED THROMBOLYSIS IN CEREBRAL INFARCTION GRADE 2B/2C/3 REVASCULARIZATION IN PATIENTS UNDERGOING DIRECT TRA (88.5%) AND DIRECT TFA (90.8%), WITHOUT STATISTICALLY SIGNIFICANT DIFFERENCES. THE MEDIAN (IQR) PUNCTURE TO RECANALIZATION TIME WAS37 (24¿58) MIN FOR THE DIRECT TRA GROUP AND 42 (28¿70) MIN FOR THE DIRECT TFA GROUP. SIGNIFICANT DIFFERENCES IN ACCESS SITE COMPLICATIONS, SYMPTOMATIC ICH, AND MRS SCORE 0¿2 AT 90 DAYS BETWEEN BOTH TRA AND TFA ACCESSES WERE NOT FOUND. OTHER OUTCOMES ARE SHOWN IN TABLE 2. THE MEDIAN (IQR) ROOM TO PUNCTURE TIME WAS SLIGHTLY HIGHER IN THE TRA GROUP (14 [10¿19] MIN) THAN IN THE TFA GROUP (12 [10¿15] MIN) (P=0.073). THE PERCENTAGE OF PATIENTS WITH ACCESS SITE COMPLICATIONS WAS HIGHER IN THE TFA THAN IN THE TRA GROUP (5.0% VS. 1.6%, P=0.354). COMPLICATIONS INCLUDED PSEUDOANEURYSM IN 1 PATIENT IN THE DIRECT TRA GROUP OF OUR INITIAL CASES IN WHOM A SPECIFIC RADIAL CLOSURE DEVICE WAS NOT USED, AND 38 PATIENTS IN THE TFA GROUP (CLAUDICATION WORSENING 2, ACUTE ISCHEMIA 3, EMBOLECTOMY 1, FEMORAL PSEUDOANEURYSM 7 [TREATED WITH THROMBIN 4], EMBOLECTOMY, AMPUTATION AND DEATH 1, AND MODERATE/SEVERE HEMATOMA WITH NO FURTHER INTERVENTION 24). THE OCCURRENCE SICH WAS ALSO SIMILAR (10.9% VS. 7.4%, P=0.322). DATA OF MRS AT 90 DAYS WAS AVAILABLE FOR 754 PATIENTS. DIFFERENCES BETWEEN THE TWO ACCESS GROUPS IN THE PERCENTAGES OF PATIENTS WITH MRS SCORES 0¿2 WERE NOT OBSERVED.   TRA IS NOT INFERIOR TO TFA IN THE PROBABILITY OF CATHETERIZATION, TIMES OF CATHETERIZATION AND REVASCULARIZATION, AND OTHER CLINICAL OUTCOMES FOR MECHANICAL THROMBECTOMY IN ACUTE STROKE.   THERE WERE NO DEVICE ISSUES REPORTED RELATING TO THE USE OF THE CELLO OR REACT CATHETERS.   ADVERSE EVENTS INCLUDED: 1. PSEUDOANEURYSM, FEMORAL PSEUDOANEURYSM 2. CLAUDICATION WORSENING 3. ACUTE ISCHEMIA 4. EMBOLECTOMY 5. MODERATE/SEVERE HEMATOMA 6. SYMPTOMATIC INTRACRANIAL HEMORRHAGE 7. DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129878 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death