BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3170166 · Received June 14, 2013

    Report

    Report Number
    2953200-2013-01124
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 2, 2007
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION, FISTULA, REMOVAL OF IMPLANT); CAUSED BY ANOTHER DRUG/DEVICE (OTHER MANUFACTURER'S DEVICE (J-WIRE) TO HELP PREVENT A TYPE II ENDOLEAK LIKELY CONTRIBUTED TO THE FISTULA). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (OTHER MANUFACTURER'S DEVICE (J-WIRE) TO HELP PREVENT A TYPE II ENDOLEAK LIKELY CONTRIBUTED TO THE FISTULA).

    Description of Event or Problem · 1

    MEDTRONIC REVIEWED THE FOLLOWING JOURNAL ARTICLE; AORTODUODENAL FISTULA AFTER ENDOGRAFT REPAIR OF ABDOMINAL AORTIC ANEURYSM SECONDARY TO A RETAINED GUIDEWIRE, HOUSSAM FARRES, HTTP://DX.DOI.ORG/10.1016/J.JVS.2012.05.069 . AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM . AORTODUODENAL FISTULA IS A WELL-KNOWN BUT UNCOMMON COMPLICATION OF BOTH PRIMARY AORTIC PATHOLOGY (INCIDENCE 0.04%-0.07%) AND PREVIOUS AORTIC GRAFT REPLACEMENT (INCIDENCE 0.36%-1.6%).1 ENDOVASCULAR STENT GRAFTS HAVE RARELY BEEN USED TO TREAT PRIMARY 2, 3 OR SECONDARY 4 AORTODUODENAL FISTULAS, USUALLY AS A TEMPORIZING MANEUVER TO CONTROL SEVERE HEMORRHAGE, FOLLOWED BY STAGED OPEN REPAIR. OCCASIONALLY, STENT GRAFTS HAVE BEEN USED AS DEFINITIVE THERAPY. SINCE THE ADVENT OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR), 20 CASES OF AORTODUODENAL FISTULA ASSOCIATED WITH AORTIC STENT GRAFTS HAVE BEEN REPORTED. MOST PUBLICATIONS ARE SINGLE CASE REPORTS, BUT A META-ANALYSIS YIELDED A 35% MORTALITY 1,5-18 MOST COMMERCIALLY AVAILABLE STENT GRAFTS HAVE HAD AT LEAST ONE REPORT OF AN AORTODUODENAL FISTULA FOLLOWING IMPLANTATION, INCLUDING ANEURX (MEDTRONIC, SANTA ROSA, CALIF; N 4), VANGUARD (BOSTON SCIENTIFIC, NATICK, MASS; N 3), ZENITH (COOK, BLOOMINGTON, IND; N 2), EXCLUDER (W. L. GORE, FLAGSTAFF, ARIZ; N 2), HOMEMADE DEVICES (N 2), AND ONE EACH FOR POWERLINK (ENDOLOGIX, IRVINE, CALIF), ANCURE (GUIDANT, ST. PAUL, MINN), ANACONDA (VASCUTEK, INCHINNAN, SCOTLAND, UK), AND ENDOFIT (LEMAITRE VASCULAR, BURLINGTON, MASS). POSTULATED ETIOLOGIES INCLUDE PERSISTENT ENDOLEAK WITH PRESSURIZATION OF THE ANEURYSM SAC, BARB PENETRATION OF THE AORTIC NECK, GRAFT MIGRATION WITH STENT KINKING OR FRACTURE, AND PRE-EXISTING PERIAORTIC INFLAMMATION, INCLUDING INFLAMMATORY OR MYCOTIC ANEURYSM OR CROHN¿S DISEASE. 18 THIS IS THE FIRST REPORTED CASE OF EMBOLIC MATERIAL INTENTIONALLY PLACED IN THE ANEURYSM SAC DURING EVAR ULTIMATELY ERODING THROUGH THE ANEURYSM SAC AND CREATING AN AORTODUODENAL FISTULA. THE PATIENT PRESENTED TO AN OUTSIDE INSTITUTION WITH AN ASYMPTOMATIC ABDOMINAL AORTIC ANEURYSM MEASURING 73 MM IN DIAMETER AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS MEASURING 68 MM IN DIAMETER ON THE RIGHT AND 31 MM ON THE LEFT. THE PATIENT UNDERWENT EVAR ON (B)(6) 2007, WITH AN ANEURX (MEDTRONIC) (PLI-10) 28-MM MODULAR BIFURCATED STENT GRAFT. THE MAIN BODY WAS DEPLOYED FIRST THROUGH A RIGHT FEMORAL APPROACH. THE LEFT LIMB WAS THEN EXTENDED WITH A 24-MM ILIAC CUFF, LANDING PROXIMAL TO THE LEFT HYPOGASTRIC ARTERY. THE PLAN WAS TO CANNULATE THE RIGHT HYPOGASTRIC ARTERY, OCCLUDE THE VESSEL WITH COIL EMBOLIZATION, AND EXTEND THE RIGHT LIMB OF THE STENT GRAFT TO THE RIGHT EXTERNAL ILIAC ARTERY. ATTEMPTS TO CANNULATE THE RIGHT HYPOGASTRIC ARTERY, HOWEVER, WERE UNSUCCESSFUL. NEVERTHELESS, THE RIGHT LIMB OF THE MODULAR STENT GRAFT WAS EXTENDED TO THE EXTERNAL ILIAC ARTERY WITH A 16-MM-DIAMETER STENT GRAFT (PLI-20) (INTENTIONAL COVERAGE) . A CATHETER WAS LEFT ADJACENT TO THE STENT GRAFT THROUGH WHICH THE RIGHT COMMON ILIAC ARTERY ANEURYSM WAS EMBOLIZED WITH MULTIPLE COILS, TWO AMPLATZER VASCULAR PLUGS (AGA MEDICAL, PLYMOUTH, MINN), AND TWO J-TIPPED STARTER WIRES (BOSTON SCIENTIFIC) IN AN EFFORT TO PROMOTE THROMBOSIS OF THE RIGHT COMMON ILIAC ANEURYSM AND TO PREVENT A TYPE II ENDOLEAK FROM THE RIGHT HYPOGASTRIC ARTERY. THE STARTER WIRES ALSO EXTENDED INTO THE AORTIC ANEURYSM SAC. SURVEILLANCE COMPUTED TOMOGRAPHY (CT) SCANS PERFORMED EVERY 6 MONTHS CONFIRMED COMPLETE THROMBOSIS OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM WITH NO EVIDENCE OF ENDOLEAK OVER THE NEXT 30 MONTHS. DURING THIS TIME, THE AORTIC ANEURYSM SAC DIAMETER DECREASED TO 66 MM. HOWEVER, 8 MONTHS FOLLOWING THE LAST CT SCAN SURVEILLANCE IN (B)(6) 2009, THE PATIENT SUFFERED A SYNCOPAL EPISODE AT HOME. CT SCAN ON (B)(6) 2010, REVEALED A LARGE TYPE IA PROXIMAL ENDOLEAK WITH MIGRATION OF THE ANEURX STENT GRAFT. BLOOD WAS PRESENT IN THE RETROPERITONEUM, ALTHOUGH NO ACTIVE EXTRAVASATION OF CONTRAST WAS IDENTIFIED. THE PATIENT WAS TRANSFERRED TO OUR INSTITUTION, WHERE URGENT PROXIMAL EXTENSION OF THE ENDOGRAFT WAS PERFORMED WITH A 36-MM DIAMETER COOK RENU AORTIC CUFF WITH SUPRARENAL FIXATION. ANTEGRADE PERFUSION TO BOTH ILIAC LIMBS OF THE ENDOGRAFT WAS PRESERVED. NO ENDOLEAK WAS PRESENT AT THE COMPLETION OF THE PROCEDURE OR ON SUBSEQUENT CT SCAN 1 MONTH LATER. SURVEILLANCE CT ANGIOGRAM 6 MONTHS LATER, HOWEVER, REVEALED GAS BUBBLES WITHIN THE THROMBOSED ABDOMINAL AORTIC ANEURYSM SAC. ALSO NOTED WAS A PERFORATION OF THE ANEURYSM SAC BY THE PREVIOUSLY PLACED J-WIRE, WHICH APPEARED TO PENETRATE THE DUODENUM. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY AND TRANSFERRED BACK TO OUR INSTITUTION. UPPER ENDOSCOPY FAILED TO CONFIRM A DUODENAL PERFORATION, BUT THE EXAMINATION DID NOT EXTEND TO THE FOURTH PORTION OF THE DUODENUM. THE PATIENT UNDERWENT A RIGHT AXILLOBIFEMORAL BYPASS WITH AN 8-MM EXTERNALLY SUPPORTED EXPANDED POLYTETRAFLUOROETHYLENE GRAFT ON (B)(6) 2011. TWO DAYS LATER, HE UNDERWENT STAGED LAPAROTOMY AND EXCISION OF THE STENT GRAFT WITH LIGATION OF THE INFRARENAL AORTA AND COMMON ILIAC ARTERIES JUST PROXIMAL TO THEIR BIFURCATION. THE J-WIRE WAS FOUND TO HAVE PENETRATED THE AORTIC ANEURYSM SAC INTO THE DUODENUM (FIG 3). THE DUODENUM WAS REPAIRED PRIMARILY, AND THE RETROPERITONEUM WAS COVERED WITH AN OMENTAL GRAFT. THE PATIENT DID WELL POSTOPERATIVELY WITHOUT COMPLICATION AND WAS TRANSFERRED TO A REHABILITATION FACILITY ON THE 8TH POSTOPERATIVE DAY. SUBSEQUENTLY, HE WAS DISCHARGED HOME ON THE 20TH POSTOPERATIVE DAY AND HAS REMAINED ASYMPTOMATIC AT 1 YEAR OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271144 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention