BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASCULAR PLUG

    MDR report key: 7818488 · Received August 27, 2018

    Report

    Report Number
    2029214-2018-00746
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    August 10, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRD
    UDI-DI
    00847536025431
    PMA / PMN Number
    K150108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MVP DEVICE (MODEL: MVP-7Q LOT: 170811) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN AN OPENED MVP INNER POUCH. THE MVP PLUG WAS RETURNED SEPARATED FROM THE PUSHWIRE. THE PUSHWIRE AND PLUG WERE RETURNED WITHIN SEPARATE PLASTIC BIO-POUCHES. THE MVP PLUG AND PUSHWIRE WERE DECONTAMINATED AS PER (B)(4). THE MVP PLUG WAS FOUND TO BE SEPARATED FROM THE PUSHWIRE AT THE DETACH ZONE. THE PROXIMAL MARKER BAND APPEARS TO BE BENT. THE PROXIMAL END OF THE PROXIMAL MARKER BAND WAS FOUND TO BE CLEAR OF OBSTRUCTION. VISUAL INSPECTION OF THE THREADED INSERT REVEALED NO IRREGULARITIES. THE PLUG WAS EXAMINED AND FOUND TO BE FULLY OPENED. HOLES WERE FOUND WITH THE PLUG MEMBRANE. THE PUSHWIRE WAS THEN EXAMINED. NO BENDS OR KINKS WERE FOUND WITH THE PUSHWIRE. THERE WERE FIVE PARTIALLY FILLED COIL GAPS FOUND WITH THE DISTAL THREADED SECTION OF THE PUSHWIRE. THERE DOES NOT APPEAR TO BE ANY EXCESS SOLDER FOUND WITH THE FIVE PARTIALLY FILLED COIL GAPS WHICH IS ACCEPTABLE AS PER (B)(4). THE DISTANCE FROM THE TIP OF THE PUSHWIRE TO THE BUS HING THREAD START WAS MEASURED TO BE 0.008" WHICH IS WITHIN SPECIFICATION (SPECIFICATION PER (B)(4). C: 0.010¿ ± 0.002). THE PLUG WAS RE-ATTACHED TO THE DISTAL END OF THE PUSHWIRE. THE DISTAL THREADED SECTION OF THE PUSHWIRE WAS COMPLETELY COVERED BY THE PLUG. WH ILE SECURING THE PLUG, A TORQUER WAS ATTACHED TO THE PROXIMAL END OF THE PUSHWIRE. THE PLUG WAS SUCCESSFULLY DETACHED FROM THE PUSHWIRE WITH ~4.5 ROTATIONS OF THE TORQUER/PUSHWIRE. NO OTHER ANOMALIES WERE OBSERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE MICROVASCULAR PLUG PREMATURELY DETACHED FROM THE PUSHER WIRE ONCE UNSHEATHED FROM THE CATHETER. THE PLUG IMMEDIATELY MIGRATED AND HAD TO BE RETRIEVED WITH A SNARE AS A RESULT. THERE WAS NO FURTHER DEVICE PLACED AFTER PLUG RETRIEVAL. THERE WERE NO RELATED PATIENT SYMPTOMS.

    Description of Event or Problem · 1

    THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS CONFIRMED THAT THE DEVICES WERE PREPARED/FLUSHED AS INDICATED PER THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660187 MICROVASCULAR PLUG DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR MVP-7Q 170811 00847536025431

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention