BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 21632138 · Received March 18, 2025

    Report

    Report Number
    2029214-2025-00691
    Event Type
    Death
    Date Received
    March 18, 2025
    Date of Event
    July 18, 2023
    Report Date
    March 18, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: CHEN ,L., XU, Y., LI, L., JI, T., WANG, Y., ZHU, W., WANG, F., ZHANG, Q.. A SINGLE-CENTER RETROSPECTIVE STUDY OF THE COCO TECHNIQUE IN THE TREATMENT OF CHRONIC INTERNAL CAROTID ARTERY OCCLUSION. J NEUROINTERVENT SURG 16:756¿763 2024. DOI: 10.1136/JNIS-2023-020451 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

    LITERATURE WAS REVIEWED REGARDING: THE STUDY TITLED "A SINGLE-CENTER RETROSPECTIVE STUDY OF THE COCO TECHNIQUE IN THE TREATMENT OF CHRONIC INTERNAL CAROTID ARTERY OCCLUSION." THE OBJECTIVE IS TO INTRODUCE A NOVEL ENDOVASCULAR RECANALIZATION METHOD (THE COCO TECHNIQUE) AND INVESTIGATE ITS SUCCESS RATE, PERIPROCEDURAL COMPLICATIONS, AND EARLY OUTCOMES IN PATIENTS WITH CHRONIC INTERNAL CAROTID ARTERY OCCLUSION (CICAO). THE TIME FRAME OF THIS STUDY WAS: THE STUDY REVIEWED DATA FROM PATIENTS WHO UNDERWENT ENDOVASCULAR RECANALIZATION BETWEEN JANUARY 2019 AND DECEMBER 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION: 6F/90 CM SHUTTLE CATHETER (OPTMED), 5F/125 CM VERTEBRAL ANGIOGRAPHIC CATHETER (CORDIS), 6F/115 CM INTERMEDIATE CATHETER (MEDTRONIC), MICROCATHETER (SL-10, STRYKER), 0.035 INCH STIFF SLIPPERY GUIDEWIRE (TERUMO), 2.5 MM BALLOON (SACSPEED, ACHEVA), ENTERPRISE 2 STENT (CODMAN), CEREBRAL PROTECTION DEVICE (SPIDERFX, MEDTRONIC) THE FOLLOWING MEDTRONIC DEVICES WERE USED: 6F/115 CM INTERMEDIATE CATHETER, CEREBRAL PROTECTION DEVICE (SPIDERFX) DEATHS OCCURRED IN THE STUDY POPULATION: DURING THE FOLLOW-UP, ONE PATIENT DIED OF SEVERE PNEUMONIA. AMONG PATIENT ADVERSE EVENTS INCLUDED: INTRAOPERATIVE COMPLICATIONS: SLIGHT SUBARACHNOID HEMORRHAGE (2 PATIENTS), ASYMPTOMATIC DISSECTION HEMORRHAGIC COMPLICATIONS (3 PATIENTS) AND POSTOPERATIVE ISCHEMIC COMPLICATIONS (3 PATIENTS), ALL IMPROVED AFTER CONSERVATIVE TREATMENT AND REHABILITATION. MALFUNCTIONS, COMPLICATIONS, SIDE EFFECTS: INTRAOPERATIVE COMPLICATIONS: DISSECTION, DISTAL EMBOLIZATION, CAROTID-CAVERNOUS ARTERIOVENOUS FISTULA, AND VESSEL PERFORATION. PERIOPERATIVE NEUROLOGICAL COMPLICATIONS: HEMORRHAGIC OR ISCHEMIC. RESTENOSIS WAS OBSERVED IN SIX (15.8%) PATIENTS. POST-OPERATIVE ISSUES: DEVELOPMENT OF ISCHEMIC EVENTS IN TWO PATIENTS DURING THE FOLLOW-UP PERIOD. CLINICAL OUTCOMES OF INTEREST: THE TECHNICAL SUCCESS RATE OF THE COCO TECHNIQUE WAS 89.8% (44/49). THE MODIFIED RANKIN SCALE SCORES WERE LOWER AT THE 3-MONTH FOLLOW-UP THAN AT BASELINE (1 (0¿2) VS 2 (1¿2), P=0.04). ONLY TWO PATIENTS EXPERIENCED RECURRENT ISCHEMIC EVENTS, INDICATING A LOWER RATE OF RECURRENT ISCHEMIA ASSOCIATED WITH SUCCESSFUL RECANALIZATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599066 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L SEE H11.