BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHERA

    MDR report key: 21686446 · Received March 25, 2025

    Report

    Report Number
    9617601-2025-00292
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 21, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    CONTINUATION OF D10: PRODUCT ID: PED2-450-30 (B811761); 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED WITH A HANGE OF STRATEGY AND A PIPELINE VANTAGE (PED3-021-350-25) WAS IMPLANTED FROM MCA TO CLINOIDAL SEGMENT. IT IS BELIEVED THE CAUSE OF RESISTANCE WAS A TWIST OF THE FLOW INSIDE THE CATHETER.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN DISTALLY, ENCOUNTERED SEVERE FRICTION OR DIFFICULTY DURING ADVANCEMENT, AND WAS STUCK IN THE DISTAL SECTION OF THE PHENOM MICROCATHETER DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT SIDE ANEURYSM WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. THE LANDING ZONE WAS 3MM DISTALLY AND 4.7MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS "OK". IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS VERY DIFFICULT TO PUSH STARTING FROM THE MIDDLE PART OF THE MICROCATHETER. THE FINAL PART WAS VERY DIFFICULT TO ARRIVE IN THE DEPLOYMENT ZONE AND THEY NEEDED A TORQUE TO PUSH AND THE DISTAL PUSHER HAD SOME KINKS DUE TO IT. ONCE DEPLOYMENT WAS INITIATED, THE STENT OPENED WITH DIFFICULTY AND IT WAS IMPOSSIBLE TO RESHEATH DESPITE RELIEVING TENSION. THE STENT WAS PULLED OUT OF THE PATIENT BECAUSE IT WAS STUCK IN THE PHENOM AND IMPOSSIBLE TO RESHEATH AND TO ADVANCE IN THE DISTAL LANDING ZONE. EVEN OUTSIDE THE PATIENT, THE STENT WAS IMPOSSIBLE TO PULL INSIDE THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS NOT DAMAGED. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER AND PHENOM 27 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133631 CATHERA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 FG15150-0630-1S 228515387

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female SEE H11