BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR2

    MDR report key: 4483221 · Received February 4, 2015

    Report

    Report Number
    2029214-2015-00092
    Event Type
    Death
    Date Received
    February 4, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 6, 2015
    Manufacturer
    IRVINE
    Product Code
    NRY
    PMA / PMN Number
    K123378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBERS WERE REVIEWED AND NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE WERE OBSERVED. THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL: SFR2-4-40, LOT: 9973253, DOM: 24 SEP 2014, EXP: 21 SEP 2016. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6). TREATMENT OF A STROKE IN EVOLUTION. THE PATIENT WAS ADMITTED TO THE ENROLLING HOSPITAL FOR "SUSPECTED RIGHT MIDDLE CEREBRAL ARTERY STROKE". THE PATIENT UNDERWENT BASELINE CT (COMPUTED TOMOGRAPHY) ANGIOGRAM ON THE SAME DAY WHICH SHOWED OCCLUSION OF THE RIGHT MCA (MIDDLE CEREBRAL ARTERY) AND A CLOT }9MM PRESENT. THE PATIENT WAS TAKEN DIRECTLY FROM THE ER (EMERGENCY ROOM) TO THE INTERVENTIONAL RADIOLOGY LAB FOR MECHANICAL THROMBECTOMY ON THE SAME DAY. THE FIRST PASS WAS MADE IN THE ANTERIOR DIVISION OF THE RIGHT MCA USING A 4MM X 20MMM SOLITAIRE 2 DEVICE. CONTRAST INJECTION AND IMAGING THROUGH THE RIGHT ICA (INTERNAL CAROTID ARTERY) WITH A GUIDE CATHETER WAS THEN PERFORMED AND IT REVEALED PERSISTENT OCCLUSION. THREE MORE PASSES WERE MADE WITH THE SOLITAIRE 2 DEVICE IN THE POSTERIOR DIVISION OF THE RIGHT MCA. TICI FLOW DEVICE SCORES WERE 0 AFTER EACH PASS. POST PROCEDURAL IMAGING WAS DONE ONE DAY POST PROCEDURE AND IT REVEALED CONTINUED PROGRESSION OF LARGE RIGHT MCA DISTRIBUTION INFARCT WITH INCREASED GRAY-WHITE MATTER LOSS AND SULCAL EFFACEMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 8 DAYS POST PROCEDURE TO A HOSPICE AND PASSED AWAY 12 DAYS POST PROCEDURE. THE PATIENT DEATH WAS POSSIBLY PROCEDURE RELATED. THE IMPRESSION OF THE NEUROLOGY ADMISSION HISTORY AND PHYSICAL, THE PHYSICIAN STATES THAT THE REASON FOR NOT OPTING FOR IV-TPA WAS DUE TO THE EXACT TIME OF THE PATIENT'S STROKE NOT BEING ESTABLISHED, EARLY CHANGES ON CT, THE PATIENT'S REPORTED HISTORY OF ANTICOAGULATION, AND THE PATIENT'S AGE. THE PHYSICIAN FELT AN INTERVENTIONAL APPROACH WITH EMBOLECTOMY WAS REASONABLE AFTER REVIEWING THE PATIENT'S MEDICAL INFORMATION WITH ANOTHER PHYSICIAN. TWO DEVICE WERE USED, THEY WERE 4 X 20 ((B)(4)) AND 4 X 40 ((B)(4)). THE NUMBER OF PASSES WITH EACH DEVICE WERE: 1 PASS WITH THE 4MM X 20MM SOLITAIRE DEVICE AND 3 PASSES WITH A 4 X 40MM SOLITAIRE DEVICE. CAUSE OF DEATH: FAILURE OF THE DEVICE TO REMOVE THE CLOT WAS STATED IN THE SOURCE. IN ADDITION, THE PATIENT'S DENIAL OF FURTHER EVALUATION OR INTUBATION LEADING UP THE PATIENT'S DECISION TO BE DISCHARGE TO HOSPICE AFTER PALLIATIVE CARE WAS DISCUSSED. THE PATIENT WAS DISCHARGED TO HOSPICE AND EXPIRED. THE CLOT PER THE DIAGNOSTIC IMAGES DEMONSTRATED RIGHT COMMON CAROTID BIFURCATION WITH ATHEROSCLEROTIC PLAQUE BUT NO STENOSIS OR FILING DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81238 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY IRVINE SOLITAIRE FR2 9962644

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death