BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17928286 · Received October 13, 2023

    Report

    Report Number
    2029214-2023-02008
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    March 1, 2014
    Report Date
    October 12, 2023
    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

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONCOMITANT MEDICAL PRODUCT: PRODUCT ID NV UNK PIPELINE (UNKNOWN); G2: CITATION: AUTHORS: LI L, GAO B-L, SHAO Q-J, ZHANG G-L, WANG Z-L, LI T-X AND ZHU L-F. SMALL UNRUPTURED INTRACRANIAL ANEURYSMS CAN BE EFFECTIVELY TREATED WITH FLOW-DIVERTING DEVICES. FRONT. NEUROL 13:913653 2022. 10.3389/FNEUR.2022.913653 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING SMALL UNRUPTURED INTRACRANIAL ANEURYSMS THAT CAN BE EFFECTIVELY TREATED WITH PIPELINE FLOW-DIVERTING DEVICES. A TUBRIDGE STENT HAD FAILURE OF STENTING, AND ALL THE OTHER PATIENTS HAD SUCCESSFUL STENT DEPLOYMENT, WITH A SUCCESS RATE OF STENTING OF 99.1% (109/110). FIVE PERI-PROCEDURAL ISCHEMIC COMPLICATIONS OCCURRED, I.E., ONE PATIENT WHO WAS TREATED WITH A PIPELINE DEVICE COMBINED WITH COILING AND FOUR TREATED WITH THE DEPLOYMENT OF A PIPELINE DEVICE ONLY, RESULTING IN A COMPLICATION RATE OF 4.5%. NO HEMORRHAGIC COMPLICATIONS TOOK PLACE IN THIS COHORT. IN ONE CASE WITH POOR STENT ADHERENCE TO THE ARTERIAL WALL, CEREBRAL INFARCTION HAD OCCURRED IN THE AREA SUPPLIED BY THE CHOROIDAL ARTERY AND ANTERIOR CEREBRAL ARTERY COVERED BY THE STENT, RESULTING IN AN MRS SCORE OF 4 AT FOLLOW-UP EVALUATION. IN ONE CASE WITH IN-STENT THROMBOSIS LEADING TO OCCLUSION OF THE MIDDLE CEREBRAL ARTERY, THE MRS WAS 5 AT FOLLOW-UP. IN ONE CASE WITH AN ATHEROSCLEROTIC PLAQUE AT THE PARENT ARTERY NEAR THE ANEURYSM NECK LEADING TO SLIGHT STENOSIS OF THE PARENT ARTERY, IN-STENT THROMBOSIS OCCURRED 4 H AFTER THE PROCEDURE, AND ACUTE ENDOVASCULAR THROMBECTOMY WAS PERFORMED, RESULTING IN RECANALIZATION AND GOOD RECOVERY OF THE PATIENT. COMPLETE OCCLUSION OF THE ANEURYSM AND AN MRS OF 0 WERE PRESENT AT THE 3-MONTH FOLLOW-UP. IN ONE CASE WITH CEREBRAL ISCHEMIC SYMPTOMS (HEMIPLEGIA), INTRAVENOUS PUMPING OF TIROFIBAN RESULTED IN GOOD RECOVERY. TWO PATIENTS HAD ASYMPTOMATIC IN-STENT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585503 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention