BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10446958 · Received August 25, 2020

    Report

    Report Number
    9612164-2020-03113
    Event Type
    Death
    Date Received
    August 25, 2020
    Date of Event
    February 19, 2020
    Report Date
    November 2, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H:6 CONCLUSION CODE UPDATED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COST-EFFECTIVENESS ANALYSIS OF CHIMNEY/SNORKEL VERSUS FENESTRATED ENDOVASCULAR REPAIR FOR HIGH-RISK PATIENTS WITH COMPLEX ABDOMINAL AORTIC PATHOLOGIES TANEVA ET AL, J CARDIOVASC SURG 2020;61:18-23. DOI: 10.23736/S0021-9509.19.11146-9. IMPLANT DATE: EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR TREATMENT OF COMPLEX ABDOMINAL AORTIC PATHOLOGIES ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED MALFUNCTIONS: TYPE I ENDOLEAKS, MIGRATION AND AN UPPER EXTREMITY SHEATH BECAME TRAPPED BY THE AORTIC STENT GRAFT PINS. SERIOUS INJURY: OCCLUSION OF RENAL STENTS, MI POSTOPERATIVE CARDIAC ARRHYTHMIA, STROKE, EMPHYSEMA AND RESPIRATORY DISTRESS, PNEUMONIA AND REINTERVENTION AND DEATH. THE CAUSE OF THE ADVERSE EVENTS ARE UNDERMINED. THE CAUSE OF DEATH IN ONE PATIENT WITHIN 30 DAYS OF THE INDEX PROCEDURE WAS DETERMINED AS PROCEDURE RELATED. MEDICAL HISTORY: SMOKING, HYPERLIPIDEMIA, COPD, PREVIOUS MI, DEGENERATIVE ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914856 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death