BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24912750 · Received April 17, 2026

    Report

    Report Number
    9617601-2026-02528
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 17, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000274870
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT, PRODUCT ID PED2-325-20 (LOT D060295); 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

    MEDTRONIC RECEIVED A REPORT THAT PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PTFE SLEEVES WERE NOT ABLE TO BE RECAPTURED. THE STENT WAS IMPLANTED AND REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, VERTEBRAL ARTERY ANEURYSM. THE LANDING ZONE ARTERIAL DIAMETER WAS 2.5 MM DISTALLY AND 3.25 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS GOOD. ANCILLARY DEVICES INCLUDED PHENOM 27 MICROCATHETER. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16196 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 232805937 00763000274870

    Patients

    Seq Age Sex Outcome Treatment
    1