BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 21562200 · Received March 10, 2025

    Report

    Report Number
    2029214-2025-00605
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    August 30, 2024
    Report Date
    March 10, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K110055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE IS THE AVERAGE AGE FROM ALL PATIENTS INCLUDED IN THE STUDY GROUP. A3A. REPORTED PATIENT SEX IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS. 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

    YAO, J., ZHENG, B., SUN, Q., ZHANG, F., JI, Z., WANG, C., WU, P., SHI, H. (2024). HYBRID SURGERY FOR SYMPTOMATIC CHRONIC INTERNAL CAROTID ARTERY OCCLUSION: A SINGLE-CENTER EXPERIENCE. ACTA NEUROCHIRURGICA: THE EUROPEAN JOURNAL OF NEUROSURGERY, 166(1). HTTP S://DOI.ORG/10.1007/S00701-024-06250-4. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE CASE SERIES WAS CONDUCTED AT A SINGLE CENTER REVIEWING CASES OF 27 PATIENTS WHO UNDERWENT HYBRID SURGERY FOR THE TREATMENT OF SYMPTOMATIC CHRONIC INTERNAL CAROTID ARTERY OCCLUSION (ICAO). IT WAS NOTED THAT PATIENT WITH ICAO ARE AT HIGH RISK FOR REOCCLUSION. THE HYBRID SURGICAL TECHNIQUE COMBINES CAROTID ENDARTERECTOMY (CEA) AND ENDOVASCULAR INTERVENTION (EI). THIS PROCEDURE INVOLVES PERFORMING CEA AT THE PROXIMAL END OF THE CAROTID ARTERY TO REMOVE ATHEROSCLEROTIC PLAQUES AND THROMBI. SUBSEQUENTLY, EI TARGETS DISTAL STENOSIS OR OCCLUSION IN THE INTERNAL CAROTID ARTERY THAT CEA CANNOT REACH, THUS SUCCESSFULLY RECANALIZING THE CHRONIC ICAO. MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE TREATMENT PROCEDURES. IN SOME CASES, THE INTERMEDIATE CATHETER WAS A NAVIEN 6F 115CM CATHETER. HOWEVER, OTHER CATHETERS WERE USED AND IT WAS NOT SPECIFIED WHICH DEVICES WERE USED IN EACH PROCEDURE. NO DEVICE MALFUNCTION OR DEFICIENCY OF THE CATHETER WAS REPORTED. IT WAS NOTED THAT SUCCESSFUL REVASCULARIZATION WAS ACHIEVED IN 100% OF CASES. THE FOLLOWING PERI-PROCEDURE ADVERSE EVENTS WERE REPORTED: ONE PATIENT DEATH OCCURRED. THE PATIENT DEVELOPED ACUTE RENAL FAILURE POST-SURGERY MARKED BY ANURIA, AND UNFORTUNATELY PASSED AWAY ON THE THIRD DAY AFTER THE OPERATION. TWO PATIENTS EXPERIENCED ISCHEMIC COMPLICATIONS. ONE OF THESE PATIENTS HAD INTRAOPERATIVE STENT THROMBOSIS, AS CONFIRMED BY DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWING THROMBI IN THE DISTAL ICA AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THIS PATIENT UNDERWENT A SUCCESSFUL MECHANICAL THROMBECTOMY AND HAD A FAVORABLE RECOVERY, EXHIBITING NO NEUROLOGICAL ISCHEMIC SYMPTOMS AND WAS DISCHARGED WITH AN MRS SCORE OF 0. THE OTHER PATIENT PRESENTED WITH LIMB WEAKNESS IN THE VASCULAR SUPPLY AREA OF THE SURGERY, CONFIRMED BY POSTOPERATIVE DIFFUSION-WEIGHTED IMAGING (DWI) AS A SMALL FOCAL ACUTE CEREBRAL INFARCTION, LIKELY DUE TO EMBOLIZATION OF DEBRIS. SYMPTOMS PARTIALLY ALLEVIATED FOLLOWING IMPROVED CIRCULATION AND REHABILITATION INTERVENTIONS. ONE PATIENT EXPERIENCED A HEMORRHAGIC COMPLICATION THAT WAS ATTRIBUTED TO THE ANTIPLATELET THERAPY. AS THERE WAS NO DEVICE MALFUNCTION AND THE EVENT WAS NOT ASSOCIATED WITH THE DEVICE OR PROCEDURE, THE HEMORRHAGIC EVENT IS NOT CONSIDERED A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451200 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention