BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6171164 · Received December 13, 2016

    Report

    Report Number
    1820334-2016-01571
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 11, 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

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND TRENDS 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. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. PER THE IFU "POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO CARDIAC COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARRHYTHMIA, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, HYPOTENSION, HYPERTENSION)." THE IFU LISTS A CONTRAINDICATION FOR PATIENTS WITH KNOWN SENSITIVITIES OR ALLERGIES TO STAINLESS STEEL, POLYESTER, POLYPROPYLENE, URETHANE, POLYTETRAFLUOROETHYLENE, NYLON, OR GOLD. DEVICES UNDERGO A VALIDATED STERILIZATION PROCESS. THE ZENITH DEVICE FUNCTIONED AS INTENDED AND DURING FOLLOW-UP, THE PATIENT DEVELOPED A COMORBID CONDITION (CARDIAC COMPLICATIONS). THE ROOT CAUSE OF THE EVENT IS LIKELY NOT DEVICE RELATED. ALTHOUGH WITHOUT APPROPRIATE IMAGING OR CLINICAL INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    VERZINI, FABIO, MD, PHD, FEBVS ET AL; "FOURTEEN-YEAR OUTCOMES OF ABDOMINAL AORTIC ENDOVASCULAR REPAIR WITH THE ZENITH STENT GRAFT." SOCIETY FOR VASCULAR SURGERY 2016; 1-12. 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. THE ARTICLE STATES THAT ONE OF THE PERIOPERATIVE DEATHS WAS ATTRIBUTABLE TO CARDIAC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822791 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death