BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 23659976 · Received November 26, 2025

    Report

    Report Number
    2029214-2025-02502
    Event Type
    Death
    Date Received
    November 26, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE IS INCLUDED IN THE ATTACHMENTS. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ACCEPTANCE OF THE ARTICLE. G.4. PMA CODE MISSING AS DEVICE MODEL AND LOT IS UNKNOWN. 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

    VU, D. L., NGUYEN, V. H., NGUYEN, H. A., NGUYEN, Q. A., TRAN, A. T., LE, H. K., NGUYEN, T. T., TRAN, C., LE, H. K., TU, D. N., TA, Q. H., NGUYEN, D. T., LE, C. C., PIEROT, L. (2025). COMPARISON OF MECHANICAL THROMBECTOMY WITH TIGERTRIEVER VERSUS SOLITAIRE X STENT RETRIEVER IN REAL-WORLD PRACTICE: A MATCHED-PAIR RETROSPECTIVE ANALYSIS. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES, 15910199251380920. HTTPS://DOI.ORG/10.1177/15910199251380920 LITERATURE WAS REVIEWED REGARDING A STUDY AIMED TO COMPARE THE SAFETY AND EFFICACY OF TIGERTRIEVER VERSUS SOLITAIRE IN MECHANICAL THROMBECTOMY (MT) FOR ACUTE ISCHEMIC STROKE DUE TO LARGE VESSEL OCCLUSION. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE X (4 MM × 20 MM/4 MM × 40 MM/6 MM × 40 MM) AND REACT CATHETER. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL MEDTRONIC DEVICES PATIENT'S ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: IN-HOSPITAL SEVERE ADVERSE EVENT , DISSECTION OR PERFORATION COMPLICATION, THROMBUS MIGRATION, SYMPTOMATIC INTRACRANIAL HEMORRHAGE, AND THE USE OF RESCUE THERAPIES (BALLOON ANGIOPLASTY AND/OR STENTING). THE SOLITAIRE X GROUP DEMONSTRATED A SIGNIFICANTLY HIGHER FIRST-PASS RECANALIZATION RATE AND REQUIRED FEWER DEVICE PASSES TO ACHIEVE SUCCESSFUL REPERFUSION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813293 REACT CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REACT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death