BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17764473 · Received September 18, 2023

    Report

    Report Number
    2029214-2023-01744
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    December 29, 2022
    Report Date
    September 18, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. NO SPECIFIC DEVICE INFORMATION PROVIDED. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    ZHANG, H., ZHANG, H., LIU, J., SONG, D., ZHAO, Y., GUAN, S., MAIMAITILI, A., WANG, Y., FENG, W., WANG, Y., WAN, J., MAO, G., SHI, H., LUO, B., SHAO, Q., CHANG, K., ZHANG, Q., HE, Y., ZHANG, P., XINJIAN, Y., LI, L., LI, T. X. PIPELINE EMBOLIZATION DEVICE FOR SMALL AND MEDIUM VERTEBRAL ARTERY ANEURYSMS: A MULTICENTER STUDY. NEUROSURGERY. 92:971¿978. 2023. DOI: 10.1227/NEU.0000000000002319 SUMMARY: PIPELINE EMBOLIZATION DEVICES (PEDS) HAVE BEEN INCREASINGLY USED FOR THE TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS. OBJECTIVE: TO INVESTIGATE THE SAFETY AND EFFICACY OF PED IN THE TREATMENT OF SMALL TO MEDIUM UNRUPTURED VERTEBRAL ARTERY INTRACRANIAL ANEURYSMS (VAIAS). DATA FROM 76 PATIENTS WITH 78 UNRUPTURED SMALL AND MEDIUM (=12 MM) VAIAS WERE ANALYZED. DATA FOR THIS STUDY COME FROM THE PLUS STUDY, WHICH WAS CONDUCTED AT 14 CENTERS IN CHINA FROM 2014 TO 2019. UNIVARIATE ANALYSES WERE PERFORMED TO EVALUATE PREDICTORS OF THE OCCLUSION AND COMPLICATION. SEVENTY-EIGHT ANEURYSMS IN 76 PATIENTS WERE TREATED WITH PED. THE MEAN ANEURYSM SIZE WAS 8.28 ± 2.13 MM, AND ALL PEDS WERE SUCCESSFULLY PLACED. THE MEDIAN FOLLOW-UP WAS 7 MONTHS AND AVAILABLE FOR 67 (85.9%) ANEURYSMS. COMPLETE OCCLUSION WAS SEEN IN 60 (89.6%) ANEURYSMS, WHICH 86.6% MET THE PRIMARY EFFICACY OUTCOME. ALL PATIENTS RECEIVED CLINICAL FOLLOWUP, THE COMBINED MAJOR MORBIDITY AND MORTALITY WAS 2.6%, AND 98.7% OF PATIENTS HAD A GOOD PROGNOSIS. ISCHEMIC STROKE OCCURRED IN 10.5% OF PATIENTS, AND ADJUVANT COIL AND SUCCESSFUL AFTER ADJUSTMENT WERE PREDICTORS OF ISCHEMIC STROKE IN THE EARLY POSTOPERATIVE AND FOLLOW-UP, RESPECTIVELY. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE OCCLUSION RATE OF ANEURYSM INVOLVING POSTERIOR INFERIOR CEREBELLAR ARTERY (P= .78). IN CASES WHERE POSTERIOR INFERIOR CEREBELLAR ARTERY WAS COVERED BY PED, THERE WAS NO SIGNIFICANT DIFFERENCE IN ISCHEMIC STROKE. IN THE TREATMENT OF UNRUPTURED =12 MM VAIAS, PED HAS A HIGH SURGICAL SUCCESS RATE, A HIGH DEGREE OF OCCLUSION, AND LOW MORBIDITY AND MORTALITY. PED MAY BE A PROMISING ENDOVASCULAR TECHNIQUE. REPORTED EVENTS: IN THE PERIOPERATIVE PERIOD, INTRAOPERATIVE THROMBOSIS WAS 2.6%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040203 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention