BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESET DELTA THROMBECTOMY DEVICE

    MDR report key: 25298084 · Received May 27, 2026

    Report

    Report Number
    3013656790-2026-00003
    Event Type
    Injury
    Date Received
    May 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    PHENOX LTD
    Product Code
    NRY
    PMA / PMN Number
    K242676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESET DEOLTA STENTS WERE LEFT BEHIND IN THE PATIENT DESPITE ATTEMPTS TO REMOVE FROM THE ARTERY. THIS FURTHER BLOCKED THE ARTERY OF THE PATIENT WHO WAS ALREADY FACED WITH A DEBILITATING STROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 5 X 40 WAS DELIVERED TO A M1 CLOT AND UPON RETRIEVAL INTO A SOFIA 88 THE PRESET DETACHED UNINTENTIONALLY, A GOOSE NECK SNARE WAS USED TO TRY TO RECOVER THE STENT BUT DID NOT WORK, ANOTHER 6 X 30 WAS INTRODUCED TO TRY TO DEPLOY AND RETRIEVE THE 5 X 40, THAT 6 X 30 ALSO DETACHED UNINTENTIONALLY. THIS MDR REPORT IS FOR THE PRESET 5 X 40 DEVICE. AN ADDITIONAL REPORT WILL BE SUBMITTED FOR THE 6 X 30 DEVICE ADDITIONAL INFO WAS RECEIVED ON 18 MAY 2026: 1. HAS THE PRESET DELTA 6-30 BEEN DISCARDED BY THE HOSPITAL, OR IS IT AVAILABLE FOR RETURN AND ROOT CAUSE ANALYSIS? ONLY THE PUSHERS WERE AVAILABLE AS THEY SEPARATED FROM THE STENT, AND THE STENTS WERE LEFT BEHIND IN THE PATIENT. 2. FOLLOWING THE DETACHMENT OF BOTH PRESET DEVICES, WERE ANY FURTHER ACTIONS TAKEN TO REMOVE THE COMPONENTS FROM THE PATIENT'S ANATOMY? THE FIRST STEP RETRIEVER DETACHED. THAT'S WHEN THE SECOND ONE WAS USED TO TRY AND SNARE AND BRING THE FIRST DEVICE OUT. SUBSEQUENTLY, THE SECOND DEVICE DETACHED. SNATCH WERE USED TO TRY AND LASSO THE DEVICES. BUT NOTHING WAS UNSUCCESSFUL. 3. WHAT WAS THE FINAL OUTCOME OF THE PROCEDURE? AFTER BOTH THE DEVICES DETACH AND WE'RE NOT ABLE TO BE RETRIEVED OR REMOVED. THEY WERE LEFT, BLOCKING THE ARTERY THAT WAS ALREADY AFFECTED BY THE STROKE. 4. WHAT WAS THE CLINICAL IMPACT ON THE PATIENT, AND WHAT IS THEIR CURRENT CONDITION? THE PATIENT WAS ALREADY FACED WITH A DEBILITATING STROKE THAT HAD ALREADY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428982 PRESET DELTA THROMBECTOMY DEVICE THROMBUS RETRIEVER NRY PHENOX LTD PRE2-5 X 40 565455

    Patients

    Seq Age Sex Outcome Treatment
    1