BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 4525467 · Received February 18, 2015

    Report

    Report Number
    2029214-2015-00170
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    October 12, 2014
    Report Date
    January 22, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATING THAT ANOTHER SOLITAIRE SFR-6-30 DEVICE WAS USED TO TREAT THE PATIENT. THE TOTAL NUMBER OF DEVICES USED IN THE PROCEDURE WAS THREE. THE INFORMATION FOR ALL THE DEVICES INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL: SFR-6-30 / LOT: 9898739 / DOM: 17 APR 2014 / EXP: 13 APR 2016 (QTY. 2) ONE OF THESE DEVICES WAS REFERENCED IN THE INITIAL MEDICAL DEVICE REPORT. THIS SUPPLEMENTAL REPORT (FOLLOW-UP 3) IS ADDING ANOTHER DEVICE FROM THE SAME LOT. MODEL: SFR-4-15 / LOT: 9828874 / DOM: 13 NOV 2013 / EXP: 11 NOV 2015 THIS DEVICE WAS REFERENCED IN THE FOLLOW-UP 1 SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. THE IFU (INSTRUCTIONS FOR USE) HAS A WARNING THAT STATES "DO NOT PERFORM MORE THAN THREE RECOVERY ATTEMPTS IN THE SAME VESSEL USING THE SOLITAIRE REVASCULARIZATION DEVICE."(B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR OTHER SOLITAIRE STENT DEVICE WAS USED IN THE PROCEDURE. MODEL# SFR-4-15 LOT# 9828874 DOM: 13 NOV 2013 EXP: 11 NOV 2015. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) STUDY. TREATMENT OF A STROKE. POST MECHANICAL THROMBECTOMY, IT WAS REPORTED THE PATIENT EXPERIENCED A MINOR SAH (SUBARACHNOID HEMORRHAGE) OBSERVED TO BE AT THE INTERPEDUNCULAR CISTERN (ASYMPTOMATIC). THE RELATIONSHIP TO THE DEVICE OR PROCEDURE WAS UNKNOWN. PRIOR TO THE EVENT, THE PATIENT PRESENTED WITH AN ACUTE STROKE AND UNDERWENT THE MECHANICAL THROMBECTOMY IN WHICH A SOLITAIRE FR (6-30) WAS USED FOR FOUR PASSES IN THE SAME VESSEL. THEN ANOTHER SOLITAIRE (4-15) WAS USED FOR THE DISTAL M1. THE EVENT OCCURRED POST PROCEDURE. THE PATIENT WAS REPORTED TO BE IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116031 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR-6-30 9898739

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other