BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR REVASCULARIZATION DEVICE

    MDR report key: 5540414 · Received April 1, 2016

    Report

    Report Number
    2029214-2016-00192
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    June 12, 2015
    Report Date
    March 8, 2016
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE LINK: (B)(4). THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. INTRACRANIAL HEMORRHAGE IS A KNOWN INHERENT RISK OF MECHANICAL THROMBECTOMY PROCEDURE AND IS DOCUMENTED IN THE SOLITAIRE FR INSTRUCTION FOR USE (IFU). SAME ARTICLE AS REPORTED IN MDR MFR: 2029214-2016-00191.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE REVIEW THAT SIX OF 89 PATIENTS (6.7%) HAD SYMPTOMATIC INTRACEREBRAL HEMORRHAGE AFTER THE PROCEDURE. IN THIS ARTICLE, THE AUTHORS RETROSPECTIVELY ANALYZED DATA OF EIGHTY-NINE PATIENTS WITH ACUTE ISCHEMIC STROKE TREATED WITH THE SOLIT AIRE FLOW RESTORATION REVASCULARIZATION DEVICE TO IDENTIFY NOTABLE FACTORS THAT AFFECT OUTCOME, REVASCULARIZATION, AND COMPLICATIONS. THREE ENDPOINTS WERE CONSIDERED: REVASCULARIZATION (THROMBOLYSIS IN CEREBRAL INFARCTION), OUTCOME (MODIFIED RANKIN SCALE SCORE), AND COMPLICATIONS. CITATION: DAOU B, CHALOUHI N, STARKE RM, ET AL. PREDICTORS OF OUTCOME, COMPLICATIONS, AND RECANALIZATION OF THE SOLITAIRE DEVICE: A STUDY OF 89 CASES. NEUROSURGERY. 2015 SEP;77(3):355-60; DISCUSSION 360-1. DOI: 10.1227/NEU.0000000000000830.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198479 SOLITAIRE FR REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR SOLITAIRE FR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Disability