BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLIGATOR RETRIEVAL

    MDR report key: 10102020 · Received May 29, 2020

    Report

    Report Number
    2029214-2020-00508
    Event Type
    Death
    Date Received
    May 29, 2020
    Date of Event
    October 29, 2019
    Report Date
    May 29, 2020
    Manufacturer
    MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K043580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABDALKADER M, ET AL. J NEUROINTERVENT SURG 2020;12:505¿511. DOI:10.1136/NEURINTSURG-2019-015278 ¿COIL MIGRATION DURING OR AFTER ENDO VASCULAR COILING OF CEREBRAL ANEURYSMS¿ MOHAMAD ABDALKADER , MICHEL PIOTIN , MICHAEL CHEN, SANTIAGO ORTEGA-GUTIERREZ, EDGAR SAMANIEGO, ALAIN WEILL, ALEXANDER M NORBASH, THANH N NGUYEN MEDTRONIC RECEIVED THE FOLLOWING INFORMATION THROUGH LITERATURE REVIEW: THERE WERE 18 /6071 CASES OF COIL MIGRATION (NO ALLEGATION OF MANUFACTURE/ UNKNOWN COILS). IN 2 OF THE 18 EVENTS, AN ALLIGATOR RETRIEVAL DEVICE WAS USED AND THROMBOEMBILZATION OCCURRED. IN 1 OF THESE 2 A DEATH WAS REPORTED. IN ANOTHER EVENT WHERE THE ALLIGATOR DEVICE WAS USED, THE PATIENT WAS REPORTED TO HAVE SUFFERED A HEMORRHAGE AND THE ALLIGATOR WAS UNABLE TO RETRIEVE THE COILS. THE ALLIGATOR DEVICE WAS USED IN THREE CASES BUT SUCCEEDED IN ONLY ONE OF THEM. PATIENTS WERE 15 MEN AND THREE WOMEN. THE MEAN AGE WAS 56.4±14.3 YEARS. ENDOVASCULAR RETRIEVAL DEVISES INCLUDED MERCI RETRIEVAL SYSTEM (CONCENTRIC MEDICAL INC, (B)(4), USA), SNARING (AMPLATZ GOOSENECK MICROSNARE MICROVENA CORP, (B)(4), USA), ALLIGATOR RETRIEVAL DEVICE (MEDTRONIC NEUROVASCULAR, (B)(4), USA), AND STENT RETRIEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564954 ALLIGATOR RETRIEVAL CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O