BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 6676776 · Received June 29, 2017

    Report

    Report Number
    2029214-2017-00845
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE OR THAT A DEVICE MALFUNCTION OCCURRED DURING THE PROCEDURE. IT IS POSSIBLE THAT THE PATIENTS¿ ANATOMY AND USED TECHNIQUE MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. HOWEVER, THE EXACT CAUSE IS UNKNOWN. HEMORRHAGES AND VESSEL WALL INJURIES ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). LINKED MDRS: 2029214-2017-00845 2029214-2017-00846. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ¿EFFECT OF RETRIEVABLE STENT SIZE ON ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE: A MULTICENTER STUDY¿ D. YANG, Y. HAO, W. ZI, H. WANG, D. ZHENG, H. LI, M. TU, Y. WAN, P. JIN, G. XIAO, Y. XIONG. HTTP://DX.DOI.ORG/10.3174/AJNR.A5232 MEDTRONIC RECEIVED THE FOLLOWING REPORTS: 628 PATIENTS WERE TREATED WITH A MECHANICAL THROMBECTOMY DEVICE, 59.2% (372/628) WERE TREATED WITH 4-MM, AND 40.6% (256/628), WITH 6-MM RETRIEVERS. THERE WERE 58.3% (366/628) MEN, AND THE AVERAGE AGE WAS 66 YEARS (RANGE, 56 ¿74 YEARS). THE MEDIAN BASELINE NIHSS SCORE WAS 17 (RANGE, 12¿21). SYMPTOMATIC INTRACEREBRAL HEMORRHAGE OCCURRED IN 101/628 OF PATIENTS WITHIN 24 HOURS AFTER ENDOVASCULAR TREATMENT. VESSEL PERFORATION OCCURRED IN 8/628; VESSEL DISSECTION OCCURRED IN 9/628; SUBARACHNOID HEMORRHAGE OCCURRED 13/628. PER THE REPORTING AUTHOR, THE ADVERSE EVENTS THAT WERE MENTIONED WERE NOT DIRECTLY CAUSED BY A MEDTRONIC DEVICES/PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457482 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other