BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE

    MDR report key: 6401401 · Received March 13, 2017

    Report

    Report Number
    2029214-2017-00179
    Event Type
    Death
    Date Received
    March 13, 2017
    Date of Event
    September 4, 2012
    Report Date
    February 18, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY REPORTED UNDER MDR# 2029214-2012-00533. THE DETACH WIRE WAS RETURNED FOR ANALYSIS WITHOUT THE STENT ATTACHED, AS IT WAS REMAINED IN THE PATIENT. VISUAL INSPECTION SHOWED NO IRREGULARITIES OUTSIDE OF THE DETACHMENT ZONE AREA. THE STENT APPEARED TO BE BROKEN AT THE PROXIMAL END OF THE NON-WORKING LENGTH STRUTS (TEARDROP STRUTS). THE FRACTURE SURFACE WAS THEN SENT OUT FOR SEM ANALYSIS. BASED ON THE FINDINGS AND THE SEM IMAGES, THE REPORT WAS CONFIRMED. THE FRACTOGRAPHIC FEATURES APPEARED CONSISTENT WITH FATIGUE ORIGINATING AT THE INNER WALL OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    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: UNWANTED DETACHMENT OF THE SOLITAIRE DEVICE DURING MECHANICAL THROMBECTOMY IN ACUTE ISCHEMIC STROKE.¿J NEUROINTERV SURG. 2016 JAN 27. PII: NEURINTSURG-2015-012156. DOI: 10.1136/NEURINTSURG-2015-012156. [EPUB AHEAD OF PRINT] MEDTRONIC RECEIVED THE FOLLOWING REPORT: SOLITAIRE FR WAS USED TO TREAT A VERTEBROBASILAR OCCLUSION. THE PATIENT¿S GLASGOW COMA SCALE WAS 2 AND INTUBATED. APPROX 3 DEVICE PASSES MADE. THE DETACHMENT OCCURRED DISTAL TO THE PROXIMAL MARK. THIS DEVICE WAS NOT REMOVED AND WAS LEFT IN THE PATIENT. MRS AT 90 DAYS WAS 6 (DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182196 SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) 9585092

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death