BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 20972522 · Received December 18, 2024

    Report

    Report Number
    2029214-2024-02377
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    April 25, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LIN MA, W., DENG, X., SI AN, M., LIU, S., <(>&<)> BIN GUO, X.. SAFETY AND ANATOMICAL OUTCOME ANALYSIS AFTER FLOW DIVERTER COVERAGE OF THE ANTERIOR CEREBRAL ARTERY. JOURNAL OF CLINICAL NEUROSCIENCE 124:73-77 2024. DOI:10.1016/J.JOCN.2024.03.027. 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: THE USE OF FLOW-DIVERSION STENTS IN THE TREATMENT OF INTRACRANIAL ANEURYSMS, THEIR IMPACT ON BLOOD FLOW, AND THE ASSOCIATED RISK OF ISCHEMIC COMPLICATIONS. MULTIPLE MANUFACTURERS ARE FOUND: A TOTAL OF 59 PATIENTS WERE TREATED WITH FLOW DIVERTERS. THIS INCLUDED 41 PIPELINE EMBOLIZATION DEVICES, 17 TUBRIDGE, AND 1 SURPASS. DEATHS OCCURRED IN THE STUDY POPULATION: NO DEATHS WERE REPORTED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: A TOTAL OF FOUR PATIENTS WERE OBSERVED TO HAVE ISCHEMIC COMPLICATIONS RELATED TO DECREASED FLOW IN THE ANTERIOR CEREBRAL ARTERY (ACA). TWO PATIENTS RECEIVED CONSERVATIVE TREATMENT, WHILE THE OTHER TWO UNDERWENT EMERGENCY INTERVENTIONAL PROCEDURES. ALL FOUR PATIENTS SHOWED SIGNIFICANT IMPROVEMENT IN THEIR SYMPTOMS. NO PATIENT DEVELOPED NEW NEUROLOGICAL SYMPTOMS DUE TO A1 OCCLUSION OR DECREASED BLOOD FLOW DURING FOLLOW-UP, AND ALL PATIENTS HAD MRS SCORES OF = 2. THE FIRST CASE EXPERIENCED THE ANGLE OF THEIR MOUTH IS DROOPING AND DECREASED MUSCLE STRENGTH IN THE LEFT LIMB. THE SECOND CASE EXPERIENCED WEAKNESS OF THE RIGHT SIDE OF THE BODY. THE THIRD CASE EXPERIENCED POOR CONSCIOUSNESS, UNRESPONSIVENESS, AND BILATERAL LOSS OF MUSCLE STRENGTH. THE FOURTH CASE EXPERIENCED WEAKNESS OF THE RIGHT SIDE OF THE LIMB. AT FOLLOW-UP THEIR MUSCLE STRENGTH IMPROVED, BUT HAD DIFFICULTY WALKING. A1 ARTERY OCCLUSION IMMEDIATELY AFTER THE PROCEDURE IN 13 PATIENTS AND AT FOLLOW-UP IN 34 PATIENTS. DECREASED BLOOD FLOW IN A1 OBSERVED IN 21 PATIENTS IMMEDIATELY AFTER THE PROCEDURE AND IN 10 PATIENTS AT FOLLOW-UP. IN-STENT STENOSIS AT FOLLOW-UP IN 4 PATIENTS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989350 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| L