BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 17751846 · Received September 14, 2023

    Report

    Report Number
    2029214-2023-01724
    Event Type
    Death
    Date Received
    September 14, 2023
    Date of Event
    May 8, 2023
    Report Date
    September 14, 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

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE, PRODUCT ID: NV UNK PIPELINE; G2: CITATION: AUTHORS: WANG, C., DONG, L., LIU, J., ZHANG, Y., WANG, K., LIU, P., YANG, X., LV, M., ZHANG, Y. PIPELINE EMBOLIZATION DEVICE VERSUS ATLAS STENT ASSISTED COILING FOR INTRACRANIAL ANEURYSM TREATMENT: A RETROSPECTIVE, PROPENSITY SCORE MATCHED STUDY WITH A FOCUS ON MIDTERM OUTCOMES AND HOSPITAL COST. JOURNAL OF NEUROINTERVENTIONAL SURGERY MAY 2023. DOI:10.1136/JNIS-2023-020173. 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.

    Description of Event or Problem · 0

    WANG C, DONG L, LIU J, ET AL. PIPELINE EMBOLIZATION DEVICE VERSUS ATLAS STENT ASSISTED COILING FOR INTRACRANIAL ANEURYSM TREATMENT: A RETROSPECTIVE, PROPENSITY SCORE MATCHED STUDY WITH A FOCUS ON MIDTERM OUTCOMES AND HOSPITAL COSTS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. MAY 2023. DOI:10.1136/JNIS-2023-020173 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE (PED). THE PURPOSE OF THIS ARTICLE WAS TO EXAMINE THE EFFECT OF DIFFERENT TREATMENT OPTIONS (PED AND ATLAS) FOR ICA ANEURYSMS ON MIDTERM OUTCOMES AND HOSPITAL COSTS. IN THE PED GROUP, THERE WERE 162 PATIENTS WITH 168 ANEURYSMS, AND THE MAJORITY (97.0%) OF ANEURYSMS WERE UNRUPTURED, INCLUDING SIX MULTIPLE ANEURYSMS. THE MEAN AGE OF THESE PATIENTS WAS 53.9 YEARS AND 78.9% WERE WOMEN. THE PIPELINE FLEX WAS USED 142/168 OF THE ANEURYSMS IN THE PED. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: ONE PATIENT THE PED GROUP DIED OF TARGET ANEURYSM RUPTURE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269390 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death SEE H10.