BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 14904943 · Received July 4, 2022

    Report

    Report Number
    9612164-2022-02494
    Event Type
    Injury
    Date Received
    July 4, 2022
    Date of Event
    June 16, 2022
    Report Date
    September 2, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    B5; ADDITIONAL INFORMATION RECEIVED: IT WAS NOT CLEAR IF THE MAIN STENT BODY GRAFT MIGRATED. IT IS BELIEVED THAT THE BENT PART NECK WAS PUSHED TOWARD THE LESSER CURVATURE SIDE AND THE CONTRALATERAL GATE WAS BLOCKED. THE GUIDE WIRE COULD NOT BE PASSED. ETEW1313C82EJ WAS ATTEMPTED TO BE ADVANCED THROUGH THE VESSEL AT THE TIME OF IMPLANT IN THE RIGHT CIA. 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 · 0

    ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT AFTER SEVERAL ATTEMPTS TO ADVANCE THROUGH THE VESSEL, THE DELIVERY SYSTEM WAS DAMAGED AND WAS UNABLE TO BE PLACED INTO THE VESSEL. VASCULAR MORPHOLOGY SUCH AS ILIAC CALCIFICATION AND BENDING WAS CONSIDERED A FACTOR. 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.

    Description of Event or Problem · 0

    AN ENDURANT LLS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 56MM ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A NARROW AORTIC NECK.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE CONTRALATERAL LIMB OF THE MAIN BODY GRAFT WAS DEPLOYED, THE FLOW DIVIDER WAS PUSHED IN AND POSITIONED INTO THE AORTIC NECK. THE CONTRALATERAL LIMB OF THE MAIN BODY GRAFT COULD NOT BE CANNULATED AND BECAME OCCLUDED. AN AUI LIKE STENT WAS CREATED USING A 202082 STENT GRAFT TO THE PROXIMAL BODY AND ON THE SAME SIDE 14MM PORTION AT THE PROXIMAL END. IT WAS REPORTED THAT A ETEW1313C82EJ WAS PLANNED TO BE IMPLANTED BUT THE DELIVERY SYSTEM COULD NOT BE ADVANCED TO THE TARGET SITE. THE PATIENT UNDERWENT A FEM-FEM BYPASS AND THE TREATMENT WAS COMPLETED WITHOUT FURTHER ISSUES.  PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS DUE TO THE PATIENT'S ANATOMY AS JUST 5CM PORTION OF THE MAIN BODY ENTERED THE NECK. THE CAUSE OF THE DIFFICULTY TO ADVANCE WAS ALSO RELATED TO THE PATIENT'S VASCULAR ANATOMY DUE TO CALCIFICATION AND TORTUOSITY. THE PHYSICIAN ALSO BELIEVES THERE ARE ISSUES WITH THE SYSTEM.  NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548985 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND ESBF2314C103EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention