BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17751853 · Received September 14, 2023

    Report

    Report Number
    2029214-2023-01725
    Event Type
    Injury
    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 (LOT: UNKNOWN); 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. SEE MANUFACTURER REPORT # 2029214-2023-01724 FOR ANOTHER REPORT FROM THIS ARTICLE. 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

    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:  - SEVEN HAD ISCHEMIC COMPLICATION (FOUR CEREBRAL INFARCTIONS AND THREE TRANSIENT ISCHEMIC ATTACKS) AND THREE HAD DELAYED ANEURYSM RUPTURE IN THE PED GROUP.  - DURING FOLLOW-UP, ISCHEMIC COMPLICATIONS OCCURRED IN FIVE PATIENTS IN THE PED GROUP.  - A WORSENED MASS EFFECT WAS OBSERVED IN FIVE PATIENTS IN THE PED GROUP IN THE FOLLOW-UP PERIOD.  - SIX PATIENTS IN THE PED GROUP HAD PARENT ARTERY STENOSIS OF 50% OR MORE.  - EIGHT PATIENTS IN THE PED GROUP HAD BRANCH ARTERY OCCLUSION.  - TWO PATIENTS IN THE PED GROUP HAD RECANALIZATION.  - FIVE PATIENTS IN THE PED GROUP HAD COMPRESSION SYMPTOMS.  - FOUR PATIENTS IN THE PED GROUP HAD A FOLLOW-UP MRS SCORE OF 2-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686312 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 Other SEE H10...