BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 21697655 · Received March 26, 2025

    Report

    Report Number
    2029214-2025-00774
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    June 27, 2024
    Report Date
    March 26, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE; PRODUCT ID: NV UNK PIPELINE; G2: CITATION: AUTHORS: BRIANNA M. DONNELLY, ANDRE MONTEIRO, MATTHEW J. RECKER, JAIMS LIM, PUI MAN ROSALIND LAI, WADY T. JACOBY, WASIQ I. KHAWAR, ALEXANDER B. BECKER, MUHAMMAD WAQAS, JUSTIN M. CAPPUZZO, JASON M. DAVIES, KENN. ENDOVASCULAR TREATMENT FOR COMPLEX VASCULAR PATHOLOGIES IN THE PEDIATRIC POPULATION: EXPERIENCE FROM A CENTER WITH DUAL-TRAINED NEUROSURGEONS. WORLD NEUROSURG 189: E696-E708 2024. DOI: 10.1016/J.WNEU.2024.06.151 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: ENDOVASCULAR TREATMENT OF COMPLEX VASCULAR PATHOLOGIES IN THE PEDIATRIC POPULATION, OFTEN PERFORMED BY NONPEDIATRIC SUBSPECIALISTS WITH ADAPTATION OF EQUIPMENT AND TECHNIQUES DEVELOPED FOR ADULT PATIENTS. THE STUDY AIMED TO REPORT ON THE CENTER¿S EXPERIENCE WITH SAFETY AND OUTCOMES OF ENDOVASCULAR TREATMENTS FOR PEDIATRIC VASCULAR PATHOLOGIES. THE TIME FRAME OF THIS STUDY WAS: JANUARY 1, 2004, TO DECEMBER 1, 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE (MEDTRONIC, DUBLIN, IRELAND), ONYX (MEDTRONIC, DUBLIN, IRELAND), REACT (MEDTRONIC, DUBLIN, IRELAND), SOLITAIRE (MEDTRONIC, DUBLIN, IRELAND), AXIUM COILS (MEDTRONIC, DUBLIN, IRELAND) DEATHS OCCURRED IN THE STUDY POPULATION THE CAUSES OF DEATH WERE: RUPTURED ANEURYSM WITH FISHER GRADE IV SUBARACHNOID HEMORRHAGE (ONE DEATHS), HEMODYNAMIC FAILURE SECONDARY TO THE DISEASE (ONE DEATH), INTRAVENTRICULAR HEMORRHAGE AFTER EMBOLIZATION (ONE DEATH) AMONG PATIENT ADVERSE EVENTS INCLUDED: ACCESS-SITE COMPLICATIONS: 2 PATIENTS (1.7%), INTRAPROCEDURAL COMPLICATIONS: 3 PATIENTS (2.5%) , TRANSIENT NEUROLOGICAL DEFICITS: 2 PATIENTS (1.7%), SEVERE IN-STENT STENOSIS OBSERVED IN 1 PATIENT (12.5%) AFTER FLOW-DIVERTER TR EATMENT, TREATED WITH ANGIOPLASTY, LEFT VERTEBRAL ARTERY DISSECTION TREATED WITH A PIPELINE EMBOLIZATION DEVICE IN 1 PATIENT (4.8%), VESSEL PERFORATION IN ANOTHER PATIENT (4.8%), POSTOPERATIVE TRANSIENT UNILATERAL NEUROLOGICAL DEFICITS IN 2 PATIENTS (9.5%), MILD L EFT-SIDED WEAKNESS IN 1 PATIENT, RESIDUAL NIDUS IN 2 PATIENTS, ALLERGIC REACTION TO CONTRAST MATERIAL IN 1 PATIENT NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695752 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

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