BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 5903304 · Received August 25, 2016

    Report

    Report Number
    2029214-2016-00747
    Event Type
    Death
    Date Received
    August 25, 2016
    Date of Event
    April 13, 2015
    Report Date
    July 29, 2016
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS REPORTED TO HAVE BEEN DISCARDED AT SITE. SUBARACHNOID HEMORRHAGE IS A KNOWN INHERENT RISK OF MECHANICAL THROMBECTOMY PROCEDURE AND IS DOCUMENTED IN THE SOLITAIRE INSTRUCTION FOR USE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. 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

    MEDTRONIC RECEIVED A REPORT THAT 1 HOUR POST MECHANICAL THROMBECTOMY PROCEDURE WITH THE SOLITAIRE DEVICE, THE PATIENT DEVELOPED ISCHEMIC STROKE AND SUB ARACHNOID HEMORRHAGE (SAH) AND EXPIRED. CAUSE OF DEATH WAS DETERMINED TO BE CAUSED BY BOTH ISCHEMIC STROKE AND SAH. THE PATIENT SUFFERED AN ACUTE STROKE LOCATED IN THE LEFT VERTEBRAL ARTERY AND WAS ADMITTED TO THE HOSPITAL. THE TARGET LESION WAS THE LEFT VERTEBRAL ARTERY, ATHEROTHROMBOSIS . THE PHYSICIAN FIRST USED THE A CLOT RETRIEVER (NON-MEDTRONIC DEVICE) FOR 2 PASSES. THEN THE SOLITAIRE WAS USED FOR 2 PASSES. THE TARGET VESSEL WAS REVASCULARIZED AND THERE WERE NO ISSUES NOTED DURING THE PROCEDURE. HOWEVER, 1 HOUR AFTER THE INTERVENTION WAS COMPLETED, THE PATIENT DEVELOPED AN ISCHEMIC STROKE AND SAH. MEDICAL INTERVENTION WAS GIVEN FOR THE ISCHEMIC STROKE, BUT NOT FOR THE SAH. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556880 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR-4-20 A007233

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death