BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24731472 · Received March 30, 2026

    Report

    Report Number
    2029214-2026-00553
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000304317
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    D3 UPDATED 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

    CONTINUATION OF D10: PRODUCT ID PED2-450-35 (D030343). 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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ISSUES WITH THE PIPELINE INCOMPLETE OPENING. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIPELINE EMBOLIZATION DEVICE WAS USED DURING A FLOW DIVERTER PROCEDURE TO TREAT AN UNRUPTURED FUSIFORM LEFT EXTRADURAL INTERNAL CAROTID ARTERY ANEURYSM (MAXIMUM DIAMETER 2.5 MM) WITH VISUAL FIELD DEFECTS DUE TO MASS EFFECT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNIT LEVEL WAS REPORTED AS TOO HIGH DUE TO CLOPIDOGREL NON-RESPONDER STATUS, SO THERAPY WAS CHANGED TO TICAGRELOR. AFTER PIPELINE DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO RECAPTURE THE PTFE SLEEVES ACCORDING TO THE INSTRUCTIONS FOR USE, BUT THIS WAS NOT POSSIBLE, AND THE SYSTEM WAS PULLED BACK/REMOVED WITH THE SLEEVES STILL OUTSIDE THE PHENOM 27 MICROCATHETER; IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THIS MANEUVER AND THE PIPELINE DEVICE STAYED IN PLACE. SUBOPTIMAL WALL APPOSITION OF THE PIPELINE DEVICE WAS OBSERVED, AND BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED, WHICH WAS REPORTED TO HAVE ADDRESSED THE SUBOPTIMAL WALL APPOSITION. THE POST-PROCEDURE ANGIOGRAPHIC RESULT WAS REPORTED AS VERY GOOD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. THE LANDING ZONE WAS 4MM DISTAL AND 4.5MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE ENVOY 7F MPD CATHETER, SOFIA EX CATHETER, AND TRANSCEND EX 0.014" GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133322 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 231688436 00763000304317

    Patients

    Seq Age Sex Outcome Treatment
    1