BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 13622393 · Received February 28, 2022

    Report

    Report Number
    2029214-2022-00326
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    August 11, 2020
    Report Date
    May 18, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED PATIENT AGE (58 YEARS) IS REPRESENTATIVE OF THE MEDIAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    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

    SUNOHARA, T., IMAMURA, H., GOTO, M., FUKUMITSU, R., MATSUMOTO, S., FUKUI, N., OOMURA, Y., AKIYAMA, T., FUKUDA, T., GO, K., KAJIURA, S., SHIGEYASU, M., ASAKURA, K., HORII, R., SAKAI, C., SAKAI, N. (2021). NECK LOCATION ON THE OUTER CONVEXITY IS A PREDICTOR OF INCOMPLETE OCCLUSION IN TREATMENT WITH THE PIPELINE EMBOLIZATION DEVICE: CLINICAL AND ANGIOGRAPHIC OUTCOMES. AJNR. AMERICAN JOURNAL OF NEURORADIOLOGY, 42(1), 119¿125. HTTPS://DOI.ORG/10.3174/AJNR.A6859. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE, SINGLE-CENTER COHORT STUDY IN WHICH 105 ANEURYSMS IN 89 PATIENTS WHICH WERE TREATED WITH 91 PIPELINEEMBOLIZATION DEVICE (PED) IMPLANTATION PROCEDURES. THE AUTHORS WERE INVESTIGATING POSSIBILITY THAT ANEURYSM NECK LOCATED ON THE OUTER CONVEXITY COULD BE A POTENTIAL PREDICTOR FOR INCOMPLETE OCCLUSION AFTER TREATMENT. A NEW MORPHOLOGIC CLASSIFICATION WAS INTRODUCED BASED ON THE INCLUDED ANGLE OF THE PARENT ARTERY AGAINST THE NECK LOCATION: OUTER CONVEXITY TYPE (INCLUDED ANGLE, 160°), INNER CONVEXITY TYPE (INCLUDED ANGLE, >200°), AND LATERAL WALL TYPE (160° INCLUDED ANGLE 200°). THIS CLASSIFICATION REFLECTS THE METAL COVERAGE RATE AND FLOW DYNAMICS. NO INTRAOPERATIVE DEVICE MALFUNCTIONS WERE REPORTED. AT THE 6 MONTH FOLLOW-UP, 43 PATIENTS WERE NOTED TO HAVE INCOMPLETE ANEURYSM OCCLUSION; 5 PATIENTS REQUIRED RETREATMENT. BY THE FINAL FOLLOW-UP ONLY 31 PATIENTS HAD INCOMPLETE OCCLUSION. NOTED POST-PROCEDURE COMPLICATIONS INCLUDED: 40 THROMBOEMBOLIC EVENTS, 6 WERE SYMPTOMATIC, AND 3 HEMORRHAGIC EVENTS, NONE OF WHICH WERE SYMPTOMATIC. ANCILLARY DEVICES: NAVIEN 5F CATHETER, MARKSMAN MICROCATHETER - NO ADVERSE EVENTS WERE ASSOCIATED WITH THE ANCILLARY DEVICES IN THE ARTICLE.

    Description of Event or Problem · 0

    ADDITION INFORMATION RECEIVED REPORTED THE ADVERSE EVENTS WERE NOT RELATED TO MEDTRONIC DEVICES. SYMPTOMATIC CEREBRAL INFARCTION/CEREBRAL HEMORRHAGE IS JUDGED TO BE IVR-SPECIFIC RATHER THAN PRODUCT-SPECIFIC. THE PATIENTS WERE 74F, 64F, 75F, 71F, 57F, 22M, AND CRANIAL NERVE PARALYSIS EXACERBATION, NEWLY APPEARANCE: 50F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760704 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention