BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 7522898 · Received May 17, 2018

    Report

    Report Number
    2029214-2018-00434
    Event Type
    Death
    Date Received
    May 17, 2018
    Date of Event
    July 22, 2017
    Report Date
    May 17, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE REPORTED INFORMATION, THERE IS NO ALLEGATION THAT A MALFUNCTION OR DEFICIENCY OF THE DEVICE OCCURRED DURING THE MECHANICAL THROMBECTOMY PROCEDURE. THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A POST PROCEDURE AND PATIENT CONDITION RELATED EVENTS THAT OCCURRED. HEMORRHAGES, EDEMA AND DEATH ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). HOWEVER, THE EXACT CAUSED REMAINS UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF ¿MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF ¿FEASIBILITY OF PERMANENT STENTING WITH SOLITAIRE FR AS A RESCUE TREATMENT FOR THE REPERFUSION OF ACUTE INTRACRANIAL ARTERY OCCLUSION¿ WOO HG1, SUNWOO L2, JUNG C1, KIM BJ3, HAN MK3, BAE HJ3, BAE YJ1, CHOI BS1, KIM JH1. AJNR AM J NEURORADIOL. 2018 FEB;39(2):331-336. DOI: 10.3174/AJNR.A5477. EPUB 2017 DEC 14. IT WAS REPORTED THAT 27 OCCLUSIONS WERE TREATED WITH A SOLITAIRE FR DEVICE. OF THESE 27 CASES, 13 PATIENTS HAD THE SFR DEVICE PERMANENTLY IMPLANTED. POST THE REPORTED INTERVENTIONS, THERE WERE 3 SYMPTOMATIC HEMORRHAGES. 7 DEATHS WERE REPORTED TO HAVE OCCURRED POST THE INITIAL INTERVENTION. 3 PATIENTS DIED OF RESPIRATORY FAILURE WITH UNDERLYING METASTATIC CANCER (BRONCHIAL BLEEDING DUE TO DISSEMINATED INTRAVASCULAR COAGULATION, SEPSIS AND PNEUMONIA, AND MALIGNANT PLEURAL EFFUSION AND PNEUMONIA) AT 3 MONTHS, AND 1 PATIENT DIED OF RESPIRATORY FAILURE WITH UNDERLYING CANCER (SEPSIS AND PANCYTOPENIA) AT 6 MONTHS. 3 PATIENTS IN THE NON-SOLITAIRE FR STENTING GROUP DIED OF CEREBRAL HERNIATION CAUSED BY MALIGNANT CEREBRAL EDEMA OR INTRACEREBRAL HEMORRHAGE AT DISCHARGE, AND 1 PATIENT DIED OF PNEUMONIA AND SEPSIS AT 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364141 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other