BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHENOM CATHETER

    MDR report key: 23341389 · Received October 20, 2025

    Report

    Report Number
    2029214-2025-02239
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    PMA / PMN Number
    K151638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AKIYAMA, R., ISHII, A., CHIHARA, H., SAKAI, C., KIKUCHI, T., OKAWA, M., IKEDO, T., TAKADA, S., MATSUKAWA, S., ARAKAWA, Y.. PIPELINE SHIELD REDUCES DIFFUSION-WEIGHTED IMAGINGDETECTED ISCHEMIA AFTER INTRACRANIAL ANEURYSM TREATMENT COMPARED WITH PIPELINE FLEX: A PROPENSITY SCORE-MATCHED RETROSPECTIVE COHORT STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY 0. DOI: 10.1136/JNIS-2025-023229 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 PIPELINE SHIELD REDUCES DIFFUSION-WEIGHTED IMAGING DETECTED ISCHEMIA AFTER INTRACRANIAL ANEURYSM TREATMENT COMPARED WITH PIPELINE FLEX: A PROPENSITY SCORE-MATCHED RETROSPECTIVE COHORT STUDY. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE FLEX EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY (PED SHIELD), PIPELINE FLEX EMBOLIZATION DEVICE, MARKSMAN MICROCATHETER, PHENOM 27 MICROCATHETER. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: THE PRIMARY OUTCOME WAS THE NUMBER OF DWI-POSITIVE LESIONS DETECTED WITHIN 48 HOURS OF THE INDEX PROCEDURE ON 3.0-TESLA MRI. THE NUMBER OF DWI-POSITIVE LESIONS IN THE PED FLEX GROUP WAS 9. THE NUMBER OF DWI-POSITIVE LESIONS IN THE PED SHIELD GROUP WAS 3. ISCHEMIC COMPLICATIONS WERE DEFINED AS ANY SYMPTOMATIC ISCHEMIC EVENT RELATED TO THE PROCEDURE WITHIN 30 DAYS, INCLUDING TRANSIENT ISCHEMIC ATTACKS. OF THE PATIENTS IN THE PED FLEX GROUP, 7% (5 PATIENTS) EXPERIENCED ISCHEMIC COMPLICATIONS. HEMORRHAGIC COMPLICATIONS WERE DEFINED AS ANY INTRACRANIAL HEMORRHAGE DETECTED ON POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) WITHIN 30 DAYS. OF THE PATIENTS IN THE PED SHIELD GROUP, 3% (2 PATIENTS) EXPERIENCED HEMORRHAGIC COMPLICATIONS. OF THE PATIENTS IN THE PED FLEX GROUP, 12% (8 PATIENTS) EXPERIENCED HEMORRHAGIC COMPLICATIONS. 8 PATIENTS TREATED WITH PED FLEX UNDERWENT REPEAT FLOW DIVERSION. 3 PATIENTS TREATED WITH PED SHIELD UNDERWENT REPEAT FLOW DIVERSION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354295 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG15 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.