BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 18383857 · Received December 22, 2023

    Report

    Report Number
    2029214-2023-02459
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    April 14, 2023
    Report Date
    December 22, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED FOR THE SERIOUS INJURIES REPORTED IN THE LITERATURE ARTICLE WHICH WERE NO ASSOCIATED WITH PATIENT MORTALITY. A2. REPORTED PATIENT AGE (55 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENT IN THE STUDY FLOW DIVERSION (FD) TREATMENT COHORT. A3. REPORTED PATIENT SEX (MALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY. ASSOCIATED WITH MDR #: 2029214-2023-02458 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

    WU, Q., WANG, C., XU, S., JI, Z., QI, J., LI, Y., YAO, J., SHI, H., WU, P. (2023). LOW-PROFILE VISUALIZED INTRALUMINAL SUPPO RT-WITHIN-ENTERPRISE OVERLAPPING-STENT TECHNIQUE VERSUS FLOW DIVERSION IN THE TREATMENT OF INTRACRANIAL VERTEBROBASILAR TRUNK DISSECTING ANEURYSMS. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 13(6), 3536¿3546. HTTPS://DOI.ORG/10.21037/QIMS-22-970 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE SINGLE-CENTER STUDY DESIGNED TO EXPLORE THE EFFICACY OF VARIOUS END OVASCULAR TREATMENT TECHNIQUES IN THE TREATMENT OF PATIENTS WITH INTRACRANIAL VERTEBROBASILAR TRUNK DISSECTING ANEURYSMS (VBTDAS). THE STUDY COMPARE ANGIOGRAPHIC AN CLINICAL OUTCOMES OF PATIENTS IN TWO TREATMENT GROUPS: 1) LOW PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) WITH A NON-MEDTRONIC OVERLAPPING STENT AND, 2) FLOW DIVERSION (FD) WITH PIPELINE EMBOLIZATION DEVICE. 91 PATIENTS WITH 95 VBTDAS WERE INCLUDED IN THE ANALYSIS. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THE LITERATURE ARTICLE. POST-OPERATIVE COMPLICATIONS OR ADVERSE EVENTS REPORTED IN THE LITERATURE ARTICLE ARE NOTED BELOW. 3 PATIENTS IN FD GROUP/TREATED WITH PIPELINE DIED DUE TO COMPLICATIONS DURING THE FOLLOW-UP PERIOD: ONE PATIENT EXPERIENCED ACUTE CEREBRAL INFARCTIONS IN THE CORRESPONDING VASCULAR TERRITORIES DURING THE FOLLOW-UP PERIOD AND CONS EQUENTLY DIED. 1 PATIENT DIED DURING THE FOLLOW-UP PERIOD DUE TO ANEURYSM RUPTURE. 1 PATIENT DIED DUE TO IN-STENT THROMBOSIS. SERIOUS ADVERSE EVENTS REPORTED IN THE ARTICLE INCLUDED: ACUTE IN-STENT THROMBOSIS DIRECTLY AFTER THE PROCEDURE WAS OBSERVED IN 1 PATIENT, AND INTRA-ARTERIAL THROMBOLYSIS WAS PERFORMED. - 2 PATIENTS EXPERIENCED BILATERAL LIMB WEAKNESS AND APHASIA DURING THE PERIPROCEDURAL PERIOD, AND HEAD CT SHOWED INTRACEREBRAL HEMORRHAGE AND CEREBRAL INFARCTIONS. THE MRS SCORES OF THESE 2 PATIENTS AT DISCHARGE WERE 4 AND 5, RESPECTIVELY. 1 PATIENT EXPERIENCED UNILATERAL LIMB WEAKNESS RESULTING IN DISABILITY DURING THE PERIPROCEDURAL PERIOD. THIS EVENT RESOLVED WITH MEDICAL TREATMENT. NON-SERIOUS ADVERSE EVENTS NOTED IN THE ARTICLE INCLUDED: 2 PATIENTS WERE NOTED TO HAVE IN-STENT STENOSIS/THROMBOSIS WITH NO RELATED SYMPTOMS OR ADDITIONAL TREATMENT REPORTED IN THE ARTICLE. COMPLETE OCCLUSION WAS REPORTED FOR 14/23 PATIENTS IN THE FINAL STUDY GROUP AND IT WAS NOTED THAT OCCLUSION WAS "ADEQUATE" IN 20/23 CASES. THUS 9 PATIENTS HAD INCOMPLETE OCCLUSION AND 3 PATIENTS HAD INADEQUATE OCCLUSION. HOWEVER, NO ADDITIONAL TREATMENT OR SYMPTOMS WERE REPORTED ASSOCIATED WITH THESE OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290348 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Disability| R