BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 20428555 · Received October 11, 2024

    Report

    Report Number
    2029214-2024-01854
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    February 23, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: RAMIREZ-VELANDIA, F., ENRIQUEZ-MARULANDA, A., FILO, J., YOUNG, M., FODOR, T. B., SCONZO, D., MURAM, S., GRANSTEIN, J. H., SHUTRAN, M., TAUSSKY, P., <(>&<)> OGILVY, C. S.. COMPARISON OF THROMBOEMBOLIC EVENTS BETWEEN PIPELINE EMBOLIZATION DEVICE (PED) SHIELD AND PED/PED FLEX: A PROPENSITY SCORE¿MATCHED ANALYSIS. NEUROSURGERY 95(2), 330¿338. 2024. DOI:10.1227/NEU.0000000000002883 A.2. THIS VALUE IS THE MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE SEX 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING "THE COMPARISON OF THROMBOEMBOLIC EVENTS BETWEEN THE PIPELINE EMBOLIZATION DEVICE (PED) SHIELD AND PED/PED FLEX". THE TIME FRAME OF THIS STUDY WAS BETWEEN 2013 AND 2023. A TOTAL OF 543 PATIENTS WITH 707 ANEURYSMS TREATED IN 605 PROCEDURES WERE INCLUDED IN THE ANALYSIS. FROM THESE, 156 ANEURYSMS WERE TREATED WITH PED WITH SHIELD (22.07%) AND 551 (77.93%) WITHOUT SHIELD TECHNOLOGY. THE MAJORITY OF THE PATIENTS WERE FEMALES (84.44%) WITH A MEDIAN AGE OF 59 YEARS THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE (PED) FIRST-GENERATION, PED FLEX, AND PED WITH SHIELD TECHNOLOGY. NO DEATHS WERE SPECIFICALLY MENTIONED IN THE PROVIDED SUMMARY. AMONG PATIENT ADVERSE EVENTS INCLUDED: -41 CASES OF THROMBOEMBOLIC COMPLICATION -45 CASES OF IN-STENT STENOSIS -15 CASES OF INTRACRANIAL HEMORRHAGE -58 CASES OF VISUAL COMPLICATIONS -93 CASES HAD INCOMPLETE OCCLUSION -25 CASES HAD MRS >2 -36 CASES NEEDED RETREATMENT NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313774 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-PED2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H11...