BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25021527 · Received April 28, 2026

    Report

    Report Number
    2029214-2026-00760
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284244
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT HAD DIFFICULT DELIVERY, FAILURE TO RECAPTURE, AND DEPLOYED IN THE WRONG PLACE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE (ARTERY SIZE) WAS 3.25MM DISTAL AND 3.73MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH THE PLATELET REACTIVITY UNITS (PRU) LEVEL OF, "THERAPEUTIC." NO IMAGES ARE AVAILABLE FOR REVIEW. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS, "PIPELINE WAS DEPLOYED, BUT IT WAS DEPLOYED FROM THE M1 DOWN INTO THE INTERNAL CAROTID ARTERY. THE PHYSICIANS PLAN WAS TO BRING THE DEVICE DOWN INTO THE ICA, BUT HE ENDED UP DEPLOYING IT FROM THE M1 DUE TO LOSING HIS ABILITY TO MANIPULATE THE ADVICE. BUT HIS SECOND OPTION IF HE WAS NOT ABLE TO GET A DEVICE TO SIT IN THE ICA APPROPRIATELY WAS TO START FROM THE ONE SO THIS WAS ACTUALLY HIS BACKUP PLAN. I THINK THE ONLY REASON WHY THIS INCIDENT DID NOT CREATE AN ISSUE FOR THE PATIENT." IT WAS REPORTED THAT "THE PIPELINE DEVICE WAS DEPLOYED, PARTIALLY AN M1, AND THEN THE PTFE SLEEVES WERE CAPTURED. THE PHYSICIAN DEPLOYED THE DEVICE TWICE AND DID RECAPTURE, AND IT WAS THE THIRD DEPLOYMENT WHEN HE LOST THE ABILITY TO RECAPTURE THE DEVICE AND WAS ONLY ABLE TO DEPLOY AS HIS OPTION. WE TRY TO RECAPTURE THE DEVICE WITH OUR PHENOM PLUS, BUT WAS TOO MUCH TO PULL IT OUT SAFELY SO THE OPTION WAS TO JUST DEPLOY THE DEVICE AND BECAUSE IT WAS IN A LOCATION THAT WAS ACCEPTABLE TO DO THAT HE WENT AHEAD AND DEPLOYED. MY CONCLUSION ISTHAT AT SOME POINT IN THE MANIPULATION THE DEVICE CAME OFF OF THE PROXIMAL BUMPER." ADDITIONAL PRODUCT EVENT DETAILS WERE PROVIDED STATING THAT, "THE TIP COIL CAME INTO OUR PIPELINE BEFORE IT WAS DEPLOYED. I HAVE NEVER SEEN THE TIP OIL COME PROXIMAL INTO OUR DEVICE. IT ALWAYS DRIVES FOR WHEN THEY PUSH ON THE WIRE TO DELIVER IT SO BECAUSE THE TIP COIL WAS BACK INTO OUR PIPELINE BEFORE WE EVER PASSED THE POINT OF THE RETURN WITH OUR PHENOM 27 THIS TELLS ME THAT OUR DEVICE WAS FREELY MOVING ON THE DELIVERY WIRE ." IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS NOT USED FOR ANY INDICATION THAT IS NOT APPROVED (OFF-LABEL). ANCILLARY DEVICES INCLUDE A 6 FR SHORT SHEATH, 6 FR BENCHMARK GUIDE CATHETER, AND A PHENOM 27 150 CM MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311840 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-375-14 B820084 00763000284244

    Patients

    Seq Age Sex Outcome Treatment
    1