BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 8117945 · Received November 29, 2018

    Report

    Report Number
    2029214-2018-01002
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 9, 2011
    Report Date
    November 29, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS NOT RETURNED FOR ANALYSIS, AS IT WAS IMPLANTED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE TO OBTAINS ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN 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. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A POST PROCEDURE RELATED EVENT. HOWEVER, THE EXACT CAUSE REMAINS UNKNOWN. NEUROLOGICAL DETERIORATION IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW OF ¿MECHANICAL THROMBECTOMY IN TWO PATIENTS USING THE SOLITAIRE AB DEVICE¿ - THE SOLITAIRE AB STENT WAS USED AS A MECHANICAL EMBOLECTOMY DEVICE FOR THE TREATMENT OF LARGE ARTERY OCCLUSIONS IN PATIENTS WITH ACUTE ISCHEMIC STROKE (OFF LABEL USE OF SAB DEVICE). A (B)(6) -YEAR-OLD MAN WAS TREATED FOR A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM, 6 DAYS AFTER ICTUS (STROKE), WITH SUBARACHNOID HEMORRHAGE (SAH0. THE PATIENT DEVELOPED A COLT AND A SAB 4-15 WAS USED TO REVASCULARIZE THE VESSEL. AFTER, AN AXIUM 4-2 AND A SAB-4-15 WERE IMPLANTED IN THE PATIENT TO TREAT THE RUPTURED ANEURYSM. POST THE ENDOVASCULAR INTERVENTION, THE PATIENT WAS REPORTED TO HAVE APHASIA. 7 DAYS AFTER THE EMBOLIZATION, THE CT SCANS SHOWED CEREBRAL INFARCTION OF THE LEFT FRONTAL, TEMPORAL AND PARIETAL LOBES. THE PATIENT WAS REPORTED TO HAVE GRADUALLY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955005 AXIUM PRIME BRPL 3D DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other