BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE RD

    MDR report key: 19106546 · Received April 15, 2024

    Report

    Report Number
    2029214-2024-00654
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 15, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-SRD (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 PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: CHEN, Z., FAN, T., ZHAO, X., HU, T., QI, H., <(>&<)> LI, D.. SAFETY AND EFFICACY OF ASPIRATION CATHETER CAT6 AND 5 FR NAVIEN IN THE ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE.. THE NEUROLOGIST 29(1): 41¿44 2024. DOI:10.1097/NRL.0000000000000521 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

    CHEN Z, FAN T, ZHAO X, HU T, QI H, LI D. SAFETY AND EFFICACY OF ASPIRATION CATHETER CAT6 AND 5 FR NAVIEN IN THE ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE. THE NEUROLOGIST. 2024;29(1):41-44. DOI:10.1097/NRL.0000000000000521 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF DEATH AND INTRACRANIAL HEMORRHAGE IN ASSOCIATION WITH SOLITAIRE FR AND NAVIEN CATHETER THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE 5 DIFFERENT AREAS OF ASPIRATION CATHETER CAT6 AND 5 FR NAVIEN, THE MOST USED CLINICAL CAT HETERS IN CHINA: ASPIRATION CATHETER PLACEMENT SUCCESS RATE (ACPSR), ADDITIONAL WIRE GUIDING RATE (AWGR), THE FIRST-PASS SUCCESS RATE (FPSR), THE FINAL REPERFUSION STATUS (FRS), AND CLINICAL RESULTS. FOR THE NAVIEN CATHETER THERE WAS AN 88% (44 PATIENTS) ASPIRATION CATHETER PLACEMENT SUCCESS RATE, ADDITIONAL WIRE GUIDING RATE OF 13.592% (14 PATIENTS), 32% (16 PATIENTS) FIRST PASS SUCCESS RATE, AND A FINAL REPERFUSION STATUS OF 86% (43 PATIENTS). THE MEAN NUMBER OF PASSES FOR THE NAVIEN CATHETER WERE 2.1 PASSES. FORTY PERCENT OF THE PATIENT'S IN THE NAVIEN CATHETER GROUP HAD A MRS SCORE OF 0 TO 2 AT THE 90 DAY FOLLOW UP. EIGHT PATIENTS DIED BEFORE THE 90 DAY FOLLOW UP. THE AUTHORS REVIEWED 103 CASES OF PATIENTS TREATED FOR LARGE VASCULAR OBSTRUCTIONS (LVO) USING MECHANICAL THROMBECTOMY (CAT 6 OR 5 FR NAVIEN CATHETERS). OF THE 103 PATIENTS, 53 PATIENTS WERE SELECTED IN THE CAT 6 GROUP AND 50 PATIENTS WERE SELECTED FOR THE NAVIEN CATHETER GROUP. BOTH GROUPS USED A SOLITAIRE FR 4/20 MM STENT DURING THE MECHANICAL THROMBECTOMY. OF THE 50 PATIENTS, THE AVERAGE AGE WAS 69 YEARS, 22 WERE FEMALE AND 28 WERE MALE. COMORBIDITIES INCLUDED HYPERTENSION (52.50%), HYPERLIPIDEMIA (36.89%), ATRIAL FIBRILLATION (45.63 %), ACTIVE TOBACCO USE (33.98 %), CORONARY ARTERY DISEASE (24.3%), DAILY ALCOHOL USE (31.1%), DIABETES MELLITUS (22.33%), AND PRIOR TRANSIENT ISCHEMIC ATTACH (TIA) OR STROKE (17.48%). FORTY-SIX PATIENTS HAD OCCLUSIONS OF THE M1 MIDDLE CEREBRAL ARTERY, 9 PATIENTS HAD OCCLUSIONS OF THE M2 MIDDLE CEREBRAL ARTERY, AND 39 PATIENTS HAD INTERNAL CAROTID ARTERY TERMINUS OCCLUSIONS. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS GIVEN TO 8 OUT OF THE 50 PATIENTS IN THE NAVIEN CATHETER GROUP. THE ARTICLE DOES STATE ADDITIONAL WIRE GUIDING WAS REQUIRED IN 13.592% OF THE NAVIEN CATHETER GROUP. IN ADDITION, 43 PATIENTS HAD A FINAL TICI SCORE OF 2B/3 AND 20 PATIENTS HAD A MRS SCORE OF 0-2 AT THE 90 DAY FOLLOW UP. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: DEATH IN 8 PATIENTS INTRACRANIAL HEMORRHAGE IN 8 PATIENTS (2 SYMPTOMATIC)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832633 SOLITAIRE RD CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SRD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening SEE H11...