BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX BIFURCATED SG W/XCELERANT DELIVERY SYSTEM

    MDR report key: 13635051 · Received March 1, 2022

    Report

    Report Number
    2953200-2022-00005
    Event Type
    Death
    Date Received
    March 1, 2022
    Date of Event
    February 21, 2022
    Report Date
    March 31, 2022
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ILXC1515135, SERIAL/LOT #: (B)(4), UDI#: (B)(4). PRODUCT ID: ILXC1515115, SERIAL/LOT #: (B)(4), UDI#: (B)(4). PRODUCT ID: ILXC151585, SERIAL/LOT #: (B)(4), UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS CONCLUSION: THE REPORTED DISTAL STENT GRAFT MIGRATION AND LEFT ILIAC LIMB OCCLUSION COULD BE CONFIRMED ON THE FILMS PROVIDED; HOWEVER THE CAUSE OF THE EVENTS COULD NOT BE FULLY DETERMINED. LACK OF PRE-IMPLANT CT¿S DID NOT ALLOW FOR A THOROUGH ASSESSMENT OF THE PRE-IMPLANT ANATOMY. POST-IMPLANT CT¿S OVER THE 15 YEARS WERE ALSO NOT PROVIDED. IT APPEARS LIKELY THAT DISEASE PROGRESSION WITH ANEURYSM MORPHOLOGY CHANGES OVER THE 15 YEARS OF IMPLANTATION AND THE PATIENT¿S CONICAL NECK ANATOMY MAY HAVE BEEN A FACTOR IN THE MIGRATION OF THE STENT GRAFT OBSERVED. POSSIBLE CONTRIBUTORS TO STENT GRAFT LIMB OCCLUSION INCLUDE THE ACUTE ANGULATION AT THE LEVEL OF THE FLOW DIVIDER, AN UNKNOWN COAGULOPATHY THAT IS NOW PRESENTING OR A PREVIOUS HISTORY OF PAD LEADING TO POOR DISTAL RUN-OFF. ANALYSIS OF THE RETURNED FILMS DID NOT REVEAL ANY OBVIOUS OUT OF SPECIFICATION STENT GRAFT INTEGRITY ISSUES. B5; ADDITIONAL INFORMATION RECEIVED : IT WAS REPORTED THAT AN INTERVENTION TOOK PLACE 3 DAYS POST THE CT. AN ENDURANT AUI AND CUFF WERE IMPLANTED LANDING AT THE LEFT LOWEST RENAL ARTERY AND EXTENDED OUT WITH A 16 X16X 56 ENDURANT LIMB INTO THE EXISTING RIGHT ILIAC LIMB, THEN PROCEEDED WITH A FEM-FEM BYPASS. THE PHYSICIAN WAS UNABLE TO DETERMINE IF ONLY MAIN BODY OR LIMBS CHANGED POSITION WITH MIGRATION. IT WAS REPORTED THAT THE PATIENT WENT TO A HOSPICE THE FOLLOWING MONTH AND IS NOW DECEASED. THE EXACT DATE OF DEATH IS UNKNOWN. PER THE PHYSICIAN, THE CAUSE OF DEATH IS UNKNOWN. B2. UPDATED H1. UPDATED 10. UPDATED CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ILXC1515135, SERIAL/LOT #: (B)(6), UBD: 2007-11-07 , UDI#: (B)(4); PRODUCT ID: ILXC1515115, SERIAL/LOT #: (B)(6), UBD: 2008-06-19, UDI#: (B)(4); PRODUCT ID: ILXC151585, SERIAL/LOT #: (B)(6), UBD: , 2008-08-30 UDI#: (B)(6). 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.

    Description of Event or Problem · 0

    AN ANEURX BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF 50MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED, APPROXIMATELY 15 YEAR AFTER THE INDEX PROCEDURE, A LEFT ILIAC LIMB OCCLUSION WAS NOTED, DURING THE FOLLOW UP CT. IT WAS STATED THAT THE TOP OF THE GRAFT LOOKED TO HAVE MIGRATED WELL BELOW THE RENAL ARTERIES. THE PATIENT WAS EXPERIENCING LEG ISCHEMIA. THE CURRENT ANEURYSM DIAMETER IS NOTED AS 64MM. NO CAUSE OF THE EVENT WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011459 ANEURX BIFURCATED SG W/XCELERANT DELIVERY SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA YRBRHXC2615165

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Other| R| D "SEE H10...."