BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NV PRODUCT

    MDR report key: 11698916 · Received April 21, 2021

    Report

    Report Number
    2029214-2021-00466
    Event Type
    Death
    Date Received
    April 21, 2021
    Date of Event
    November 27, 2019
    Report Date
    April 21, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MANUFACTURER REPORT # 2029214-2021-00465 FOR THE SOLITAIRE DEVICE RELATED TO THIS ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KHANNA O, MOUCHTOURIS N, SWEID A, ET AL. TRANSRADIAL APPROACH FOR ACUTE STROKE INTERVENTION: TECHNICAL PROCEDURE AND CLINICAL OUTCOMES. STROKE AND VASCULAR NEUROLOGY. 2019;5(1):103-106. DOI:10.1136/SVN-2019-000263. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THROMBECTOMY PROCEDURES USING A TRANSRADIAL APPROACH. THE THROMBECTOMY ITSELF CAN BE PERFORMED VIA A RANGE OF DEVICES AVAILABLE, INCLUDING SOLITAIRE STENT-RETRIEVE (MEDTRONIC), RIPTIDE ASPIRATION SYSTEM (MEDTRONIC), PENUMBRA SYSTEM (PENUMBRA), AND EMBOTRAP (CERENOVUS). THE PURPOSE OF THIS ARTICLE WAS TO RETROSPECTIVELY REVIEW OUTCOMES IN THROMBECTOMY PATIENTS UNDERGOING ACUTE STROKE INTERVENTIONS VIA TRANSRADIAL ACCESS. A TOTAL OF 15 CONSECUTIVE PATIENTS WERE INCLUDED IN THE STUDY (9 MALES AND 6 FEMALES), AND ALL PATIENTS WERE ABLE TO SUCCESSFULLY UNDERGO MECHANICAL THROMBECTOMY VIA RADIAL ARTERY ACCESS. THE MEAN AGE WAS 72 YEARS OLD (RANGE: 59¿90). THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE OR RIPTIDE DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: - 2 PATIENTS (13%) DIED DURING THEIR HOSPITALIZATION. - ONE PATIENT INCURRED AN IATROGENIC VESSEL DISSECTION DURING THE PROCEDURE (WHICH WAS MANAGED VIA ASPIRIN THERAPY POSTOPERATIVELY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598836 UNKNOWN NV PRODUCT CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-GENERAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death