BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM

    MDR report key: 8297189 · Received February 1, 2019

    Report

    Report Number
    2029214-2019-00069
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    May 1, 2018
    Report Date
    February 1, 2019
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL DETAILS; HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THROMBUS FORMATION IS KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JUNIOR, Z. D., GATTO, L. A., KOPPE, G. L., TATIANA F. VON HERTWIG DE OLIVEIRA, FRANCISCO, A. N. (2018). RESCUE THERAPY WITH STENT RETRIEVERS FOR THROMBOEMBOLISM DURING ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS. ARQUIVOS DE NEURO-PSIQUIATRIA, 76 (5), 332-338. DOI: 10.1590/0004-282X20180027. MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW OF "RESCUE THERAPY WITH STENT RETRIEVERS FOR THROMBOEMBOLISM DURING ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS". PER THE ARTICLE, 10 PATIENTS OF 543 THAT UNDERWENT ENDOVASCULAR TREATMENT EXPERIENCED THROMBOEMBOLISM. THESE PATIENTS WERE INITIALLY TREATED WITH THE FOLLOWING DEVICES, ECHELON 10, SILVERSPEED10, AXIUM 3D, AXIUM HELIX, HYPERFORM 4X7, SOLITAIRE 4X15 AND 4-20. IN ALL CASES BUT ONE, THE THROMBUS WAS NOTED AT THE END OF THE PROCEDURE. FOUR PATIENTS RECEIVED INTRAVENOUS RTPA AND ONE RECEIVED REOPRO, ALL WITHOUT OPENING THE VESSEL. FIVE PATIENTS RECEIVED RTPA (FOUR INTRA-ARTERIALLY AND ONE INTRAVENOUSLY), WHILE ANOTHER RECEIVED INTRA-ARTERIAL REOPRO® BEFORE THE USE OF THE STENT RETRIEVER. THE SOLITAIRE® 4 X 15 STENT WAS USED IN FIVE PATIENTS AND THE 4X20 IN FIVE PATIENTS. RETRIEVAL WAS SUCCESSFUL IN EIGHT PATIENTS, WITH A CONTROL ANGIOGRAM SHOWING COMPLETE RECANALIZATION IN FIVE PATIENTS (MTICI 3). GOOD RECANALIZATION, MTICI 2B, WAS ACHIEVED IN THREE PATIENTS, AND POOR RECANALIZATION, MTICI 2A, WAS ACHIEVED IN TWO PATIENTS. IN THE EARLY POSTOPERATIVE PERIOD, FIVE PATIENTS HAD A NORMAL NEUROLOGICAL EXAMINATION AND MAINTAINED A MRS 0. THREE PATIENTS SHOWED INITIAL FOCAL DEFICITS, WITH PARTIAL RECOVERY AT DISCHARGE. REPERFUSION WAS LATE/INSUFFICIENT IN TWO PATIENTS, WITH ISCHEMIA SEEN ON THE POSTOPERATIVE CT SCAN. DURING THE TREATMENT OF PATIENT 1, WITH MECHANICAL DETACHABLE COILS LED TO DISTAL ANTERIOR CEREBRAL ARTERY O CCLUSION. ONE OF THESE PATIENTS, WITH A BASILAR ARTERY ANEURYSM, HAD AN INTRASTENT (SOLITAIRE 4-15) THROMBOSIS AND EVOLVED WITH THE EMBOLUS MIGRATING FORWARD TO THE P2 SEGMENT OF THE RIGHT POSTERIOR CEREBRAL ARTERY AFTER STENT RETRIEVAL. ALTHOUGH AN EMBOLECTOMY WAS PERFORMED, HE PRESENTED WITH RIGHT HOMONYMOUS HEMIANOPIA AND MAINTAINED A MRS OF 3. UNFORTUNATELY, ONE PATIENT SUFFERED A LEFT MIDDLE CEREBRAL ARTERY STROKE WITH HEMORRHAGIC TRANSFORMATION AND UNDERWENT A DECOMPRESSIVE CRANIECTOMY, BUT BECAME BEDRIDDEN AND DEPENDENT, WITH A MRS 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89505 AXIUM DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention