BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHENOM CATHETER

    MDR report key: 22959807 · Received September 3, 2025

    Report

    Report Number
    2029214-2025-01958
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    February 18, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MAESTRO, V., MURIAS, E., CAMPO, D. L., RODRÍGUEZ CASTRO, J., PUIG, J., CHAVIANO, J., LÓPEZ-CANCIO, E., CALLEJA, S., & VEGA, P. STENT RETRIEVER AS DISTAL FILTER FOR ENDOVASCULAR MANAGEMENT OF ACUTE ATHEROSCLEROSIS-RELATED CAROTID OCCLUSIONS: PRELIMINARY FINDINGS WITH A NOVEL TECHNIQUE. JOURNAL OF CLINICAL MEDICINE 14, 1352 2025. DOI.ORG/10.3390/JCM14041352 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. A2 AGE AND A3A SEX IS AVERAGE OF STUDY COHORT.  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.

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6 CODING UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED. 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

    MAESTRO, V., MURIAS, E., CAMPO, D. L., RODRÍGUEZ CASTRO, J., PUIG, J., CHAVIANO, J., LÓPEZ-CANCIO, E., CALLEJA, S., & VEGA, P.; JOURNAL OF CLINICAL MEDICINE; 2025; 14, 1352; STENT RETRIEVER AS DISTAL FILTER FOR ENDOVASCULAR MANAGEMENT OF ACUTE ATHEROSCLEROSIS-RELATED CAROTID OCCLUSIONS: PRELIMINARY FINDINGS WITH A NOVEL TECHNIQUE; DOI.ORG/10.3390/JCM14041352 LITERATURE WAS REVIEWED REGARDING BRIEF REPORT STENT RETRIEVER AS DISTAL FILTER FOR ENDOVASCULAR MANAGEMENT OF ACUTE ATHEROSCLEROSIS-RELATED CAROTID OCCLUSIONS: PRELIMINARY FINDINGS WITH A NOVEL TECHNIQUE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PHENOM 21 BALLOON GUIDE CATHETER. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: 3 PATIENTS HAD DISTAL EMBOLISM IN THE SAME TERRITORY AND ONE HAD DISTAL EMBOLISM IN THE NEW TERRITORY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED NO MALFUNCTIONS NOR ANY ADVERSE EVENTS CAUSED BY OR ASSOCIATED WITH THE PHENOM 21 MICROCATHETERS. NO OTHER MEDTRONIC DEVICES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335555 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG13 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other