BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN

    MDR report key: 20621050 · Received November 6, 2024

    Report

    Report Number
    9617601-2024-00279
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    January 28, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRA
    UDI-DI
    00847536026278
    PMA / PMN Number
    K091559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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

    MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE ENCOUNTERED RESISTANCE IN THE MARKSMAN CATHETER RESULTING IN UNINTENDED MOVEMENT DURING DEPLOYMENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 25 MM AND A 10 MM NECK DIAMETER. THE LANDING ZONE: DISTAL: 3.5 MM AND PROXIMAL 3.8 MM.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS STANDARD. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE OPERATOR FIRST PLACED THE CATHETER FA-55160-1030 (224314029) TO THE DISTAL END OF THE PARENT ARTERY. THE DE PLOYMENT POSITION AND FEEL WERE NORMAL. THE OPERATOR FIRST SELECTED A PED-375-25 BLOOD FLOW DIVERSION DENSE MESH STENT. AFTER PASSING THROUGH THE STARTING END OF FA-55160-1030 (224314029), DURING THE DELIVERY OF PED-375-25, THE PUSHING RESISTANCE INCREASED, CAUSING THE DELIVERY CATHETER FA-55160 -1030 (224314029) FELL INTO THE ANEURYSM CAVITY ALONG WITH A SECTION OF THE STENT DURING DELIVERY, AND REPEATEDLY TRIED TO PUSH THE CATHETER TO THE DISTAL END OF THE PARENT ARTERY, BUT FAILED. IT WAS REPORTED THE PIPELINE BECAME STUCK (LOCKED UP) IN THE CATHETER OR RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE DID NOT BECOME STUCK. THE CATHETER AND PUSHWIRE WERE NOT DAMAGED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 2024-02-20 E1 (FOR, HCP, REP): ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS THAT THE ANEURYSM PATH WAS TORTUOUS, CAUSING EXCESSIVE RESISTANCE. MULTIPLE PIPELINES WERE NOT USED AND HAD BEEN REMOVED. THE PIPELINE WAS REMOVED. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE PIPELINE SLIPPED FROM THE DISTAL END OF THE ANEURYSM. THE TIP OF THE CATHETER MOVED AND SLIPPED FROM THE DISTAL END OF THE ANEURYSM. 2024-APR-07 (B)(4), EMAIL (FOR, REP, SDY): NO NEW EVENT INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991529 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC MEXICO S. DE R.L. DE CV FA-55160-1030 224314029 00847536026278

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female