BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6174635 · Received December 14, 2016

    Report

    Report Number
    1820334-2016-01595
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 31, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL AND VISUAL INSPECTION WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE. PER THE IFU " VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE GRAFT AND/OR MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. INCORRECT DEPLOYMENT OR MIGRATION OF THE ENDOPROSTHESIS MAY REQUIRE SURGICAL INTERVENTION. AS THE SHEATH AND/OR WIRE GUIDE IS WITHDRAWN, ANATOMY AND GRAFT POSITION MAY CHANGE. CONSTANTLY MONITOR GRAFT POSITION AND PERFORM ANGIOGRAPHY TO CHECK POSITION AS NECESSARY." BASED ON THE PROVIDED INFORMATION AND RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT CONCLUSIVELY BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE JOURNAL ARTICLE, "FOURTEEN-YEAR OUTCOMES OF ABDOMINAL AORTIC ENDOVASCULAR REPAIR WITH THE ZENITH STENT GRAFT" FABIO VERZINI, VASCULAR SURGERY UNIT, S. MARIA DELLA MISERICORDIA HOSPITAL, UNIVERSITY OF PERUGIA, PERUGIAA; AND GRUPPO VILLA MARIA (GVM) RESEARCH AND CARE, ROME THE OBJECTIVE OF THE STUDY WAS TO INVESTIGATE THE LONG TERM OUTCOMES OF ENDOVASCULAR AAA REPAIR (EVAR) USING THE ZENITH ENDOGRAFT, STILL IN USE WITHOUT MAJOR MODIFICATION, IN A SINGLE CENTER EXPERIENCE. OF THE 610 PATIENTS WHO PARTICIPATED IN THE STUDY, 567 (93%) OF THEM WERE MALE AND THE AVERAGE AGE OF THE PATIENTS WAS 73.7 YEARS. KEF 02DEC2016 ON PAGE SIX IN THE RESULTS SECTION,THE ARTICLE STATES THAT IN ONE CASE ILIAC LIMB OCCLUSION OCCURRED AND REQUIRED REINTERVENTION. THE OCCLUSION RECURRED AND REQUIRED A SECOND INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824898 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention