BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 20784813 · Received November 26, 2024

    Report

    Report Number
    9612164-2024-05540
    Event Type
    Death
    Date Received
    November 26, 2024
    Date of Event
    November 12, 2024
    Report Date
    February 6, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IME CODES E0301, E0306, E0509 & E120206 SUBMITTED ON ASSOCIATED REGULATORY REPORT #9612164-2024-05540 REMOVED AS THESE ARE UNDERLYING CONDITIONS THAT THE PATIENT ALREADY SUFFERED PRIOR TO THE PROCEDURE AND NOTED AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    FILM EVALUATION SUMMARY: THE REPORTED STENT GRAFT AND VESSEL OCCLUSION, WHICH WERE REPORTED TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WERE CONFIRMED ON THE FILMS PROVIDED. ALTHOUGH THE CAUSE OF THE OCCLUSION COULD NOT CONCLUSIVELY BE DETERMINED, IT IS LIKELY THAT EXTENDING THE DISTAL SEAL INTO A SEVERELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY MAY HAVE CONTRIBUTED TO THE NARROWING OF THE STENT GRAFT LUMEN IN THE AREA, LEADING TO BLOOD FLOW DISTURBANCES, THROMBUS FORMATION, AND SUBSEQUENT OCCLUSION. OTHER POSSIBLE CONTRIBUTORS INCLUDE PATIENT-ASSOCIATED COMORBIDITIES, AN UNKNOWN COAGULOPATHY THAT IS NOW PRESENTING, OR A PREVIOUS HISTORY OF PERIPHERAL ARTERY DISEASE (PAD) LEADING TO POOR DISTAL RUN-OFF. ANALYSIS OF THE RETURNED FILMS DID NOT REVEAL ANY OBVIOUS OUT-OF-SPECIFICATION STENT GRAFT INTEGRITY ISSUES. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOW ING:ENLW1613C120EE, SERIAL/LOT #: (B)(6), UBD: 04-JUN-2026, UDI#: (B)(4); PRODUCT ID: ENLW1613C120EE, SERIAL/LOT #: (B)(6), UBD: 04-JUN-2026, UDI#: (B)(4); PRODUCT ID: ENBF2813C170EE, SERIAL/LOT #: (B)(6), UBD: 26-AUG-2026, UDI#: (B)(4). 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED : IT WAS CLARIFIED TE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE INTERVENTION PROCEDURE 3 WEEKS P OST-INDEX PROCEDURE AND EXPIRED 3 DAYS LATER. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILILAC ANEURYSMS. IT WAS REPORTED APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE THE PATIENT EXPERIENCED PAIN IN THE RIGHT LOWER LEG FOR 8 HOURS. CT SHOWED RIGHT ILIAC AND FEMORAL ARTERY OCCLUSION WITH DISTAL FEMORAL ARTERY EMBOLISM. NO OBVIOUS BLOOD FLOW SIGNALS WERE DETECTED IN THE FEMORAL, POPLITEAL, ANTERIOR TIBIAL, POSTERIOR TIBIAL, AND DORSALIS PEDIS ARTERIES OF THE RIGHT LOWER EXTREMITY. STENT SHADOWS WERE SEEN IN THE ABDOMINAL AORTA, BILATERAL COMMON ILIAC ARTERIES, AND EXTERNAL ILIAC ARTERIES, AND MURAL THROMBI WERE SEEN OUTSIDE THE STENTS. THROMBOEMBOLISM WAS SEEN IN THE STENTS OF THE RIGHT COMMON ILIAC AND EXTERNAL ILIAC ARTERIES AND PATENCY IN THE LEFT COMMON ILIAC AND EXTERNAL ILIAC ARTERY STENTS. ULTRASOUND CONFIRMED RIGHT ILIAC ARTERY OCCLUSION. THE PATIENT UNDERWENT THROMBECTOMY. UROKINASE WAS ALSO SLOWLY INJECTED TO DISSOLVE THE THROMBUS. AFTER THROMBECTOMY, ANOTHER ANGIOGRAPHY SHOWED THAT THERE WERE STILL MANY FILLING DEFECTS IN THE RIGHT ILIAC ARTERY STENT, AND BLOOD FLOW WAS NOT SMOOTH, SO THE BALLOON THROMBECTOMY WAS PERFORMED AGAIN. DURING THE OPERATION, THE BALLOON RUPTURED, SO ANOTHER THROMBECTOMY BALLOON WAS TAKEN OUT TO REPEATEDLY REMOVE MULTIPLE THROMBI THROUGH THE RIGHT ILIAC ARTERY. SEVERE STENOSIS OF THE RIGHT ILIAC WAS TREATED WITH BALLOON DILATION. AND BARE METAL STENTS IMPLANTED WHICH SHOWED IMPROVEMENT TO STENOSIS. THROMBOLYSIS WAS COMPLETED TO THE RIGHT FEMORAL WAS COMPLETED. THE PATIENT WAS TRANSFERRED TO ICU POST OP, HOWEVER EXPIRED. PER THE PHYSICIAN THE CAUSE OF DEATH WAS RELATED TO THE OCCLUSION OF THE RIGHT ILIAC ARTERY IN ADDITION TO THE FOLLOWING CONDITIONS HYDRONEPHROSIS (BILATERAL), MILD ANEMIA, SEVERE STENOSIS OF THE RIGHT ILIAC ARTERY; HEPATIC INSUFFICIENCY; SEPTIC SHOCK; SEPSIS; MILD ANEMIA; HYDRONEPHROSIS (BILATERAL); HYPERKALEMIA; ISCHEMIA OF THE RIGHT LOWER LIMB; GRADE 2 HYPERTENSION; TYPE 2 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405072 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENLW1613C120EE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| D "SEE H11...."