BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 19508851 · Received June 11, 2024

    Report

    Report Number
    9612164-2024-02763
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 11, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: UNKNOWN ENDURANT GRAFT S/N: UNKNOWN; USE BY DATE: UNKNOWN; UPN # UNKNOWN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AN ENDURANT  STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED POST THE INDEX PROCEDURE INTERVENTION FOR A SAC ENLARGEMENT CAUSED BY A SUSPECTED TYPE IA AND/OR TYPE IB ENDOLEAK WAS COMPLETED USING ENDOANCHORS AND DISTAL FIXATION. ETCF3232C40EE V31399518 WAS CORRECTLY DEPLOYED BELOW THE LOWEST RENAL AND 7MM ABOVE THE TOP OF THE PREVIOUS ENDOGRAFT FABRIC. A SENSH1828W 00189414 INTRODUCER WAS INSERTED INTO THE FEMORAL ARTERY AFTER ETCF3232C49EE DELIVERY SYSTEM WAS TAKEN OUT. ETLW1616C82EE V31399113 WAS THAN CORRECTLY DEPLOYED AS A LEFT DISTAL EXTENSION LANDING JUST ABOVE THE LEFT HYPOGASTRIC. PROPER MOLDING WITH A RELIANT BALLOON WAS DONE IN THE PROXIMAL, DISTAL AND OVERLAP PARTS. THE FIRST 3 ENDOANCHORS WERE DELIVERED WITHOUT PROBLEMS BUT THEN THE HG-16-62-28 BECAME KINKED AND THE APPLIER COULD NOT GET OUT FROM THE HG-16-62-28 WHEN CURVED (EVEN CURVED JUST A LITTLE), IT COULD ONLY COME OUT WHEN HG-16-62-28 WAS TOTALLY STRAIGHTENED UP. A SECOND HG-16-62-28 (SAME LOT NUMBER 0012130329) WAS USED HOWEVER THE VERY SAME ISSUE OCCURRED SO AN ATTEMPT WITH ANOTHER SA-85 SYSTEM (SAME LOT NUMBER 0012197606) WAS COMPLETED, BUT WITH THE SAME RESULT. THE PHYSICIAN WAS ABLE TO END THE PROCEDURE DELIVERING THE OTHER 5 ENDOANCHORS (8 TOTAL) BU DOING THE FOLLOWING: TOTALLY STRAIGHTENING UP THE HG-16-62-28, PUSHING THE SA-85 TIP OUT AND ONLY THEN CURVING THE HG-16-62-28 TO GET IN POSITION. FINAL ANGIO CONTROL WAS GOOD AND NO ENDOLEAKS WERE SHOWN.  PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS AND GUIDE AND APPLIER ISSUES ARE UNDETERMINED. IT WAS NOTED THAT VESSEL MORPHOLOGY WAS NOT A CAUSE FOR THE GUIDE KINKING AS A SHEATH WAS USED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295847 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention "SEE H11...."