BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 9690958 · Received February 10, 2020

    Report

    Report Number
    2029214-2020-00133
    Event Type
    Death
    Date Received
    February 10, 2020
    Date of Event
    February 1, 2019
    Report Date
    February 10, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS. DEATH IS A KNOWN INHERENT RISKS OF ENDOVASCULAR PROCEDURE AND IS DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENTS. REFERENCE MDRS: 2029214-2020-00133 2029214-2020-00134. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HUANG X., YANG Q., SHI X., XU X., GE L., DING X., ZHOU Z. (2018). PREDICTORS OF MALIGNANT BRAIN EDEMA AFTER MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE. J NEUROINTERVENT SURG; 0:1¿6. DOI:10.1136/NEURINTSURG-2018-014650. MEDTRONIC LITERATURE REVIEW REVEALED PATIENTS DEVELOPING MALIGNANT BRAIN EDEMA (MBE) AFTER MECHANICAL THROMBECTOMY (MT) WITH SOLITAIRE STENT. THE STUDY USED INFORMATION FROM 130 CONSECUTIVE PATIENTS WHO UNDERWENT MT WITH SOLITAIRE STENT WITH THE FOLLOWING CRITERIA: TIME FROM ONSET TO GROIN PUNCTURE (OTP) <(><<)>= 8 HRS; BASELINE ASPECT SCORE >= 6; BASELINE NIHSS SCORE >= 6; PRE-STROKE MRS SCORE <(><<)> 2; HAS A LARGE VESSEL OCCLUSION STROKE (LVOS) IN THE ICA OR THE M1 SEGMENT OF THE MCA. THE MEDIAN AGE WAS 68.6 AND THERE WERE 65 MALES. FROM THE TOTAL PATIENTS, 104 HAD SUCCESSFUL RECANALIZATION. OF THESE 104 SUCCESSFUL RECANALIZATION PROCEDURES, THERE WERE 27 PATIENTS WITH MORTALITY AT 90 DAYS, BUT THE CAUSE OF DEATH WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149289 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death