BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE

    MDR report key: 20365231 · Received October 3, 2024

    Report

    Report Number
    2029214-2024-01780
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    March 23, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE; PRODUCT ID: NV UNK PIPELINE; PRODUCT ID: UNK-NV-MARKSMAN; PRODUCT ID: UNK-NV-ECHELON; G2: CITATION: AUTHORS: DONG, L., WANG, C., WEI, D., PENG, Q., WU, X., CHEN, X., LI, M., LI, T., LIU, H., ZHAO, Y., DUAN, R., JIN, W., ZHANG, Y., WANG, Y., LV, M.. SPONTANEOUS DELAYED MIGRATION OR SHORTENING AFTER PIPELINE EMBOLIZATION DEVICE TREATMENT OF INTRACRANIAL ANEURYSM: INCIDENCE, MANAGEMENT, AND RISK FACTORS. JOURNAL OF NEUROINTERVENTIONAL SURGERY APRIL 2024. DOI:10.1136/JNIS-2024-021535. 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 'SPONTANEOUS DELAYED MIGRATION OR SHORTENING AFTER PIPELINE EMBOLIZATION DEVICE TREATMENT OF INTRACRANIAL ANEURYSM: INCIDENCE, MANAGEMENT, AND RISK FACTORS' (PAGE 1). THE TIME FRAME OF THIS STUDY WAS FROM APRIL 2016 TO APRIL 2022 (PAGE 2). MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE (PED) MARKSMAN MICROCATHETER PHENOM-27 MICROCATHETER ECHELON-10 MICROCATHETER (PAGES 1 AND 2) DEATHS OCCURRED IN THE STUDY POPULATION: NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: PATIENT OUTCOME: TOTAL COHORT: 790 PATIENTS TREATED WITH PEDS. SDMS (SPONTANEOUS DELAYED MIGRATION OR SHORTENING): 24 (3.04%) PATIENTS. EIGHTEEN OF THE 24 PATIENTS HAD TYPE I SDMS AND DID NOT REQUIRE RETREATMENT, WHILE THE REMAINING SIX PATIENTS HAD TYPE II SDMS AND ALL RECEIVED RETREATMENT. SDMS TYPE I REFERS TO THE PED SHORTENING OR MIGRATION DURING ANGIOGRAPHY FOLLOW-UP BUT IT STILL COMPLETELY COVERS THE ANEURYSM NECK, WHILE SDMS TYPE II REFERS TO THE PED SHORTENING OR MIGRATION DURING ANGIOGRAPHY FOLLOW-UP AND DOES NOT COMPLETELY COVER THE ANEURYSM NECK OR THE END OF THE PED FALLS INTO THE ANEURYSMAL SAC. SIX OF THE 24 SDMSS WERE WITH PED CLASSIC DEVICES, AND 18 WERE PED FLEX. COMPLICATIONS IN THE NON-SDMS GROUP: INTRAOPERATIVE COMPLICATIONS: INTRAOPERATIVE ANEURYSM RUPTURE: 3 PATIENTS. ACUTE THROMBOTIC EVENTS: 6 PATIENTS. POSTOPERATIVE COMPLICATIONS: DELAYED ANEURYSM RUPTURE OR DISTAL INTRAPARENCHYMAL HEMORRHAGE: 11 CASES. MAJOR STROKE: 3 CASES. POSTOPERATIVE MAJOR ISCHEMIC STROKE WAS DEFINED AS A CHANGE IN THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OF >4 POINTS THAT LASTED FOR >7 DAYS. MINOR STROKE: 7 CASES. POSTOPERATIVE MINOR STROKE WAS DEFINED AS A CHANGE IN THE NIHSS SCORE OF =4 THAT LASTED FOR 7 DAYS OR A TRANSIENT NEUROLOGICAL DEFICIT WITH OR WITHOUT IMAGING EVIDENCE. POSTOPERATIVE HEMORRHAGE STROKE: 9 CASES. TRANSIENT ISCHEMIC ATTACK: 9 CASES. IN-STENT STENOSIS: 28 CASES. COMPLICATIONS IN THE SDMS GROUP: ONE INTRAOPERATIVE ACUTE THROMBOTIC EVENT. ONE CASE OF MINOR STROKE. ONE CASE OF TRANSIENT ISCHEMIC ATTACK. ONE CASE OF IN-STENT STENOSIS BALLOON ANGIOPLASTY TO IMPROVE PED WALL APPOSITION WAS PERFORMED IN 23 PATIENTS IN THE NON-SDMS GROUP, AND 3 PATIENTS IN THE SDMS GROUP. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172928 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female SEE H11.