BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER UNK GUIDE CATHETER

    MDR report key: 21135526 · Received January 13, 2025

    Report

    Report Number
    1220452-2025-00002
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    November 14, 2023
    Report Date
    February 10, 2025
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K103386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TAKUMA NISHIMOTO, FUMIAKI OKA, KOKI OKAZAKI, HIROKAZU SADAHIRO, TAKAYUKI OKU, HIDEYUKI ISHIHARA. "SAFETY OF TAILORED TRANSFEMORAL CAROTID ARTERY STENTING FOR SYMPTOMATIC ELDERLY PATIENTS: A SINGLE CENTER OBSERVATIONAL STUDY". WORLD NEUROSURGERY, NO. 181:E1038-E1046, 2024, DOI: 10.1016/J.WNEU.2023.11.031. PMID: 37967746. A2: AVERAGE AGE A3: MAJORITY GENDER B3: DATE OF PUBLICATION 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WAS NO CAUSAL RELATIONSHIPS BETWEEN THE LAUNCHER AND GUARDWIRE DEVICES AND ANY OF THE ADVERSE EVENTS REPORTED. 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

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED "SAFETY OF TAILORED TRANSFEMORAL CAROTID ARTERY STENTING FOR SYMPTOMATIC ELDERLY PATIENTS: A SINGLE CENTER OBSERVATIONAL STUDY". THIS RETROSPECTIVE STUDY EXAMINED WHETHER TAILORED TRANSFEMORAL CAROTID ARTERY STENTING (TFCAS) FOR SYMPTOMATIC ELDERLY PATIENTS IS AS SAFE AS THAT FOR SYMPTOMATIC NON-ELDERLY PATIENTS. A TOTAL OF 185 PATIENTS WERE INCLUDED IN THE STUDY FROM APRIL 2010 TO MARCH 2022, 51 WERE IN THE AGED 70 YEARS OLD GROUP (GROUP Y) AND 134 WERE IN THE AGED =70 YEARS OLD GROUP (GROUP E). EXCEPT FOR AGE, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS. THE PRIMARY OUTCOME WAS MAJOR STROKE INCLUDING ISCHEMIC STROKE OR INTRACRANIAL HEMORRHAGE (ICH) WITH SYMPTOMS LASTING >24 HOURS WITHIN 30 DAYS AFTER THE PROCEDURE. THE SECONDARY OUTCOME WAS MINOR STROKE OF TRANSIENT ISCHEMIC ATTACK (TIA), AN ASYMPTOMATIC ISCHEMIC LESION (AIL), ACUTE STENT THROMBOSIS (AST), HYPERPERFUSION (HP), AND CEREBRAL HYPERPERFUSION SYNDROME (CHS). EACH PATIENT RECEIVED ORAL DUAL ANTIPLATELET THERAPY (DAPT) OF ASPIRIN (100 MG/DAY) PLUS CLOPIDOGREL (75 MG/DAY) OR PRASUGREL (3.75 MG/DAY) OR CILOSTAZOL (200 MG/DAY) FOR AT LEAST 7 DAYS BEFORE TFCAS. A TAILORED TFCAS STRATEGY WAS PERFORMED UNDER LOCAL ANESTHESIA USING A FEMORAL APPROACH WITH AN 8F OR 9F LONG SHEATH. AT THE START OF THE PROCEDURE, HEPARIN WAS GIVEN INTRAVENOUSLY. SELECTIVE ANGIOGRAPHY WAS PERFORMED, AND THE SELECTED GUIDE CATHETER WAS INTRODUCED INTO THE IPSILATERAL CCA. IF THE CASE WAS NOT THOUGHT TO NEED BALLOON PROTECTION, AN 8F MEDTRONIC LAUNCHER GUIDE CATHETER WAS USED. IN PRINCIPLE, THE GUIDE CATHETER WAS USED SIMPLY TO INTRODUCE THE CATHETER, AND A PROXIMAL EMBOLIC PROTECTION DEVICE (EPD) WAS USED IN HIGH-RISK PATIENTS WITH NEAR OCCLUSION, SEVERE TORTUOSITY, AND UNSTABLE PLAQUES. THE MEDTRONIC GUARDWIRE WAS AMONG THE EPD DEVICES USED. AFTER INTRODUCTION OF THE SELECTED DISTAL EDP, MOST CASES UNDERWENT PRE-DILATATION USING A 3.0MM OR 3.5MM BALLOON CATHETER. SELECTED STENTS WERE DEPLOYED IN THE STENOTIC LESION. POST-DILATION WAS PERFORMED TO DILATE RESIDUAL STENOSIS TO <(> <<)>30%. ALL PATIENTS RECEIVED SELECTED ANTIPLATELET THERAPY STARTING ON THE DAY AFTER THE PROCEDURE. FOLLOWING TFCAS, ANTIPLATELET THERAPY WAS CONTINUED FOR AT LEAST 1 MONTH. AMONG ALL CASES, 181 PROCEDURES WERE PERFORMED AS PER PREOPERATIVE PLANNING. ALL ISCHEMIC COMPLICATIONS INCLUDING MAJOR ISCHEMIC STROKE, TIA AND ASYMPTOMATIC ISCHEMIC LESION (AIL), WERE DETECTED IN 21 PATIENTS, INCLUDING 3 IN GROUP Y AND 18 IN GROUP E. THERE WERE 7 PATIENTS WITH 30-DAY PERIPROCEDURAL MAJOR STROKE. OF 5 PATIENTS WITH MAJOR ISCHEMIC STROKE, 3 DEVELOPED MILD HEMIPARESIS DUE TO IPSILATERAL EMBOLISM, 1 HAD IPSILATERAL VISUAL IMPAIRMENT DUE TO EMBOLISM VIA THE IPSILATERAL EXTERNAL CAROTID ARTERY (OPHTHALMIC ARTERY), AND 1 DEVELOPED A VISUAL FIELD DEFECT DUE TO EMBOLISM VIA THE VERTEBROBASILAR ARTERY. THERE WERE 2 ICH CASES; ONE DEVELOPED HEADACHE AND MILD HEMIPARESIS DUE TO IPSILATERAL ICH AT THE PUTAMEN, AND THE OTHER SUFFERED HEADACHE WITH IPSILATERAL SUBARACHNOID HEMORRHAGE. NO DEATH OR MYOCARDIAL INFARCTION OCCURRED DURING THE 30-DAY OBSERVATION PERIOD, AND THERE WAS NO DISABLING STROKE WITHIN 30 DAYS POST-INTERVENTION. IN MINOR STROKE CASES, 2 PATIENTS HAD TIA THAT WAS IPSILATERAL TRANSIENT HEMIPARESIS. AIL WAS DETECTED IN 14 PATIENTS, INCLUDING 12 LESIONS ON THE IPSILATERAL SIDE AND 2 ON THE NON-IPSILATERAL SIDE. AST WAS FOUND IN 4 PATIENTS, OF WHOM ONE DEVELOPED SYMPTOMATIC ISCHEMIC STROKE AND ADDITIONAL ANGIOPLASTY WAS PERFORMED 10 DAYS AFTER THE PROCEDURE. THE OTHER 3 PATIENTS WERE ASYMPTOMATIC AND WERE IMPROVED BY ADDITIONAL ANTIPLATELET OR ANTICOAGULANT DRUGS. NINE PATIENTS HAD HP, AMONG WHOM 2 DEVELOPED CHS AND 2 DEVELOPED ICH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567223 LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| O