BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE¿ REVASCULARIZATION DEVICE

    MDR report key: 6568202 · Received May 15, 2017

    Report

    Report Number
    2029214-2017-00653
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 19, 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO ALLEGATION THAT THE DEVICE WAS DEFECTIVE OR THAT A MALFUNCTION OCCURRED. PER THE AUTHOR, THE EVENTS REPORTED MAY HAVE BEEN RELATED TO THE MULTIPLE PASSES WITHIN ATHEROSCLEROTIC VESSELS. PER OUR DEVICE¿S INSTRUCTION FOR USE: DO NOT PERFORM MORE THAN THREE RECOVERY ATTEMPTS IN THE SAME VESSEL USING REVASCULARIZATION DEVICES. DO NOT USE EACH REVASCULARIZATION DEVICE FOR MORE THAN TWO FLOW RESTORATION. INTRACRANIAL HEMORRHAGES ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE 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 RELATED EVENT.

    Description of Event or Problem · 1

    CITATION: "PREDICTORS FOR SYMPTOMATIC INTRACRANIAL HEMORRHAGE AFTER ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE" HAO Y1, YANG D1, WANG H1, ZI W1. STROKE. 2017 APR 3. PII: STROKEAHA.116.016368. MEDTRONIC RECEIVED REPORT OF 21 CENTERS IN (B)(4), WHERE 632 PATIENTS WERE TREATED FOR ACUTE ISCHEMIC STROKE, 628 (99.4%) WERE TREATED WITH SOLITAIRE AND 4 (0.6%) WITH TREVO. INTRACRANIAL HEMORRHAGE (ICH) WAS REPORTED IN 313 PATIENTS (49.5%) WITHIN 72 HOURS AFTER ENDOVASCULAR TREATMENT. THE 101/632 WERE CLASSIFIED AS SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH). THIS WAS ALLEGED TO HAVE BEEN CAUSED BY MULTIPLE PASSES BEING CONDUCTED WITH THROMBECTOMY DEVICE IN PATIENTS WITH ATHEROSCLEROTIC VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349027 SOLITAIRE¿ REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other