BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 4892903 · Received July 6, 2015

    Report

    Report Number
    2029214-2015-00754
    Event Type
    Death
    Date Received
    July 6, 2015
    Report Date
    June 10, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS GENERATED TO CAPTURE THE DEATH. THIS ARTICLE CAN BE LOCATED AT WWW.NCBI.NLM.NIH.GOV/PUBMED/23549161 THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE REASON THE DEVICES WERE NOT RETURNING WAS NOT PROVIDED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT PERI AND POST PROCEDURE AND THE EXACT CAUSE WAS UNKNOWN. NOTE: PER THE SOLITAIRE FR IFU (INSTRUCTIONS FOR USE) WARNINGS: DO NOT USE EACH SOLITAIRE FR REVASCULARIZATION DEVICE FOR MORE THAN TWO FLOW RESTORATION RECOVERIES. MDR# 2029214-2015-00753 REFERENCE (B)(4).

    Description of Event or Problem · 1

    CITATION: MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF APETSE K, MECHTOUFF L, CHO T, MECHANICAL THROMBECTOMY WITH THE SOLITAIRE STENT AT LYON, FRANCE. EUR NEUROL 2013;69:325-330. 12 PATIENTS WERE TREATED WITH SOLITAIRE FR (7 FEMALES AND 5 MALES). THE AUTHOR STATED THAT 3 PASSES WERE MADE AND THE MECHANICAL THROMBECTOMY (MT) PROCEDURE WAS REPEATED IF REQUIRED. IT WAS REPORTED THAT THERE WAS ONE DEATH RELATED TO PERIPROCEDURAL SYMPTOMATIC CEREBRAL HEMORRHAGE. THE AUTHOR STATED THAT 3 PASSES WERE MADE AND THE MECHANICAL THROMBECTOMY (MT) PROCEDURE WAS REPEATED IF REQUIRED. PATIENTS MEAN AGE WAS 66, 7 FEMALES AND 5 MALES. THREE OTHER PATIENTS WERE ALSO REPORTED TO HAVE SUSTAINED HEMORRHAGE COMPLICATION POST TREATMENT, THE CAUSE WAS NOT REPORTED. 2 /3 PATIENTS HAD MRS 5 AND ONE HAD MRS 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435401 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SOLITAIRE FR

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death