BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACT CATHETER

    MDR report key: 22150651 · Received June 5, 2025

    Report

    Report Number
    2029214-2025-01310
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    UDI-DI
    00847536044197
    PMA / PMN Number
    K182097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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

    MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2025, HEALTHCARE PROVIDER (HCP) WAS PERFORMING AN EMERGENCY THROMBECTOMY. THE PATIENT WAS AN ACUTE LARGE ARTERY OCCLUSION PATIENT WITH THE LESION AT THE TERMINAL OF THE INTERNAL CAROTID ARTERY. THE SURGEON PLANNED TO USE THE SOLITACT TECHNOLOGY FOR THROMBECTOMY. AFTER THE MICRO-GUIDEWIRE MICRO-CATHETER ESTABLISHED THE ACCESS, THE MICRO-CATHETER PERFORMED PROXIMAL AND DISTAL ANGIOGRAPHY TO CLARIFY THE PROXIMAL AND DISTAL POSITIONS OF THE THROMBECTOMY AND PREPARE TO DELIVER THE THROMBECTOMY STENT. THE STENT SELECTED WAS SFR-6-30. THE SURGEON REPORTED THAT DURING THE PUSH PROCESS, THERE WAS GREAT RESISTANCE NEAR THE Y VALVE. THE SURGEON TRIED TO INCREASE THE FORCE TO PUSH, BUT THE RESISTANCE WAS STILL GREAT. THE SURGEON WITHDREW THE STENT, PERFORMED SECONDARY HYDRATION, AND PUSHED AGAIN, BUT THE SAME RESISTANCE PHENOMENON STILL OCCURRED. FOR THE SAKE OF SURGICAL SAFETY, THE SURGEON DID NOT PUSH THE STENT WITH BRUTE FORCE, WITHDREW THE STENT, AND OBSERVED THE STENT BODY MORPHOLOGY. THE SURGEON BELIEVED THAT THE STENT HAD SOME MORPHOLOGICAL CHANGES. FOR THE SAKE OF SURGICAL SAFETY, DELIVERING THE STENT AGAIN MAY INCREASE THE RISK. THE SURGEON THEN REPLACED IT WITH THE SFR-4-20 THROMBECTOMY STENT, SUCCESSFULLY DELIVERED AND DEPLOYED IT, AND AFTER STAYING FOR FIVE MINUTES, RAISED REACT-71, COMBINED WITH PULLING, AND SUCCESSFULLY COMPLETED THE THROMBECTOMY. THERE WAS RESISTANCE DURING THE PROCEDURE DURING DELIVERY. THE VESSEL WAS NOT TORTUOUS. THE RESISTANCE OCCURRED IN THE PROXIMAL SECTION OF THE CATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A TERMINAL OF INTERNAL CAROTID ARTERY ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 4, PROCEDURE 4. BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 15, POST PROCEDURE 4. BASELINE TICI 0, POST-PROCEDURE 3. IV TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT CONTRAINDICATED. THERE WERE 2 PASSES WITH THE DEVICE. STROKE ONSET TO REPERFUSION TIME WAS 4 HOURS. PATIENT MEDICAL HISTORY INCLUDES HIGH BLOOD PRESSURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE STENT DETACH POINT WAS SUSPECTED TO BE KINKED. A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTION FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80092 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 B662368 00847536044197

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male