BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 8725550 · Received June 23, 2019

    Report

    Report Number
    2029214-2019-00596
    Event Type
    Injury
    Date Received
    June 23, 2019
    Date of Event
    August 5, 2018
    Report Date
    June 23, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K141491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYMPTOMATIC INTRACRANIAL HEMORRHAGE AT 24 + 8 HOURS POST STUDY PROCEDURE WHICH WAS REVEALED THROUGH AN MRI IMAGE. THE EVENT WAS INVESTIGATED TO DETERMINE CAUSE. AS THE DEVICE HAD BEEN DISPOSED OF, NO ANALYSIS COULD BE PERFORMED. THE SOLITAIRE FR PERFORMED AS INTENDED AS DURING MECHANICAL THROMBECTOMY PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMATIC INTRACRANIAL HEMORRHAGE POST SOLITAIRE PROCEDURE. THERE IS NO ALLEGATION THAT THE SOLITAIRE CAUSED OR CONTRIBUTED TO THE SYMPTOMATIC INTRACRANIAL HEMORRHAGE. SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (SICH) IS A KNOWN COMPLICATION OF THROMBOLYSIS AND OR MECHANICAL THROMBECTOMY TREATMENT OF PATIENTS WITH ACUTE ISCHEMIC STROKE. IN RECENT RANDOMIZED CLINICAL TRIALS WITH PRIMARILY STENT RETRIEVERS INCLUDING MR CLEAN,ESCAPE, SWIFT PRIME, EXTEND-IA, AND REVASCAT, THERE WERE NO SIGNIFICANT DIFFERENCES IN SICH BETWEEN T REATMENT AND CONTROL GROUPS. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POTENTIAL MANUFACTURING ISSUE AND NO DHR WAS REQUESTED, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. THE INVESTIGATION DETERMINED THAT THIS WAS A KNOWN EVENT, AND THEREFORE NO NEW FORMAL INVESTIGATION WAS REQUIRED. COMMON SEQUENCES OF EVENTS AND CONTRIBUTING FACTORS THAT CAN LEAD TO THIS KNOWN EVENT ARE DOCUMENTED IN THE RISK MANAGEMENT FILE. NO CORRECTIVE ACTION IS REQUIRED. THESE TYPES OF EVENTS WILL BE MONITORED AS PART OF POST MARKET VIGILANCE COMPLAINT TRENDING AND MONITORING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAD A SYMPTOMATIC INTRACRANIAL HEMORRHAGE AT 24 + 8 HRS POST STUDY PROCEDURE WHICH WAS REVEALED THROUGH AN MRI IMAGE. PRIOR TO THE EVENT, THE PATIENT PRESENTED WITH NIHSS OF 9 AND MTICI OF 1. FOLLOWING MECHANICAL THROMBECTOMY WITH THE MEDTRONIC STENT, THE PATIENT HAD MTICI SCORE OF 2B AFTER THE FINAL PASS. PATIENT¿S NIHSS 24 POST PROCEDURE WAS NOT DONE. POST PROCEDURE, REVASCULARIZATION WAS IN GOOD CONDITION AND THE PATIENT WAS DISCHARGED HOME FIVE DAYS POST PROCEDURE IN STABLE CONDITION WITH MRS OF 1 AND NIHSS OF 3. THE HEMORRHAGE THAT OCCURRED POST PROCEDURE DID NOT REQUIRE ANY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519054 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR2-4-40 A658010

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability