BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 11848408 · Received May 19, 2021

    Report

    Report Number
    9612164-2021-01961
    Event Type
    Death
    Date Received
    May 19, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 19, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169467514
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA NUMBER: P100021. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ILIAC ARTERY RUPTURED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE LIMB DEVICE INTO ILIAC ARTERY. A RELIANT BALLOON WAS THEN ADVANCED AND INFLATED IN ORDER TO CONTROL BLEEDING. IT WAS STATED THAT A FLANK INCISION WAS PERFORMED TO REPAIR THE ILIAC ARTERY WHEN PATIENT WENT INTO CARDIAC ARREST REQUIRING CPR. AFTER 20 MINUTES OF CPR, THE PATIENT WAS PRONOUNCED DEAD. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY, DUE TO TORTUOUS CALCIFIED LEFT ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747847 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1620C93E 00643169467514

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| R