BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17878103 · Received October 5, 2023

    Report

    Report Number
    2029214-2023-01948
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    February 9, 2023
    Report Date
    October 5, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: OH, H. S., BAE, J. W., HONG, C., KIM, K. M., YOO, D. H., KANG, H.-S., & CHO, Y. D.. STENT-ASSISTED COIL EMBOLIZATION VERSUS FLOW-DIVERTING STENT IN UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS: EFFICACY AND SAFETY COMPARISON. NEUROSURGERY 1 2023. DOI:10.1227/NEU.0000000000002384 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. 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

    OH HS, BAE JW, HONG C, ET AL. STENT-ASSISTED COIL EMBOLIZATION VERSUS FLOW-DIVERTING STENT IN UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS: EFFICACY AND SAFETY COMPARISON. NEUROSURGERY. 2023;93(1):120-127. DOI:10.1227/NEU.0000000000002384 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF INFARCTION AND TIA IN ASSOCIATION WITH THE PIPELINE DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE STENT-ASSISTED COIL EMBOLIZATION (SACE) AND FLOW-DIVERTING STENT (FDS) DEPLOYMENT AS TREATMENTS FOR UNRUPTURED VERTEBRAL ARTERY DISSECTING ANEURYSMS (VADAS), FOCUSING ON EFFICACY AND SAFETY. A TOTAL OF 72 VADAS (WOMEN: 40/72, 55.5%; MEAN AGE, 56.70 YEARS) WERE SUBMITTED TO SACE OR FDS BETWEEN APRIL 2009 AND SEPTEMBER 2021. SACE WAS USED FOR 48 ANEURYSMS, AND FDS DEVICES FOR 24. FOR SACE TECHNIQUE, EITHER A 5- OR 6-FR GUIDING CATHETER WAS INTRODUCED. ONCE A 0.014-IN MICROWIRE WAS IN PLACE, A MICROCATHETER (0.021 OR 0.017 IN) WAS ADVANCED INTO THE DISSECTING ANEURYSM. STENT UTILIZATION WAS AS FOLLOWS: NEUROFORM ATLAS (N = 2; STRYKER NEUROVASCULAR), ENTERPRISE (N = 31; CODMAN NEUROVASCULAR), LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (N = 14; MICROVENTION), AND NEUROFORM EZ (N = 1; STRYKER NEUROVASCULAR). EACH ANEURYSM WAS COILED AS SOLIDLY AS POSSIBLE. FOR FDS IMPLANTATION, A 6-FR LONG SHEATH WAS INTRODUCED, AN INTERMEDIATE CATHETER (5-FR) WAS INSERTED INTO AFFECTED VA, AND A 0.027-IN MICROCATHETER WAS ADVANCED INTO BASILAR ARTERY (OVER DISSECTING ANEURYSM). ALL STENTS WERE DEPLOYED FROM NORMAL PARENT ARTERY DISTALLY TO NORMAL PARENT ARTERY PROXIMALLY, FULLY COVERING DISSECTED SEGMENTS. WALL APPOSITION STATUS WAS GAUGED BY CONT ROL ANGIOGRAM, WITH ULTRACOMPLIANT BALLOON ANGIOPLASTY SERVING TO IMPROVE APPOSITION AS NEEDED. STENT UTILIZATION WAS AS FOLLOWS: PIPELINE EMBOLIZATION DEVICE (N = 13; MEDTRONIC), SURPASS EVOLVE (N = 9; STRYKER NEUROVASCULAR), AND FLOW REDIRECTION ENDOLUMINAL DEVICE (N = 2; MICROVENTION). THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE DEVICE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -24 ANEURYSMS SHOWED SIGNS OF RECANALIZATION (MAJOR, 14; MINOR, 10) AT 6-MONTH FOLLOW-UP; 6 PATIENTS HAD MINOR RECANALIZATION AND 4 HAD MAJOR RECANALIZATION IN THE FDS TREATMENT GROUP. -PROCEDURAL AND DELAYED COMPLICATIONS WERE SIMILAR FOR BOTH SUBSETS. DELAYED ISCHEMIA (SACE, 6.3%; FDS, 8.3%) WAS SIMILAR IN THE TREATMENT SUBSETS AND NO HEMORRHAGIC COMPLICATIONS EMERGED, REGARDLESS OF MODALITY USED. 2 PATIENTS IN THE FDS TREATMENT GROUP HAD DELAYED COMPLICATIONS; ONE PATIENT HAD TIA AND ONE PATIENT HAD INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063456 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other