BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6169952 · Received December 13, 2016

    Report

    Report Number
    1820334-2016-01573
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    July 19, 2016
    Report Date
    August 17, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE 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 " ADDITIONAL ENDOVASCULAR INTERVENTIONS AND CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING AN ENLARGING ANEURYSM, UNACCEPTABLE DECREASE IN FIXATION LENGTH(VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. IMPLANT PROCEDURE STATES "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." BASED ON THE INFORMATION PROVIDED 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.

    Additional Manufacturer Narrative · 1

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

    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." 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. ON PAGE FOUR IN THE RESULTS SECTION, THE ARTICLE STATES THAT THERE WERE 87 INTRAOPERATIVE ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823333 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other