BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 22079164 · Received May 23, 2025

    Report

    Report Number
    1820334-2025-00591
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    September 22, 2025
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. INVESTIGATION ¿ EVALUATION: COOK WAS INFORMED OF FOUR DEVICES WITH TYPE IB ENDOLEAKS ON AN UNKNOWN ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THIS WAS PRESENTED IN THE ARTICLE ¿THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS¿ IN THE JOURNAL OF ENDOVASCULAR THERAPY. INTRODUCTION: ENDOVASCULAR AORTIC REPAIR (EVAR) OF INFRARENAL ABDOMINAL AORTOILIAC ANEURYSMS (AAA) HAS EMERGED AS A LESS INVASIVE AND PREFERABLE MODALITY OF TREATMENT THAN OPEN SURGERY IN THE PAST YEARS, WITH SATISFACTORY, RELIABLE RESULTS, AND BOTH TECHNIQUES ACHIEVING A SIGNIFICANT REDUCTION IN SHORT- AND LONG-TERM MORTALITY. HOWEVER, EVAR HAS RELATIVELY LOW PERIOPERATIVE COMPLICATION RATE, WHICH IS RESPONSIBLE FOR THE INCREASING USE OF THE ENDOGRAFTS IN ALL SUITABLE PATIENTS, PARTICULARLY THOSE WITH AN INCREASED SURGICAL RISK. THERE ARE SEVERAL ENDOGRAFTS AVAILABLE FOR EVAR OF AAA, WITH DIFFERENT PROSTHETIC MATERIAL COVERING THE METAL FRAMEWORK OF ENDOGRAFTS AND DIFFERENT MECHANISMS OF AORTA FIXATION (INFRARENAL, SUPRARENAL), AIMING TO EXCLUDE THE ANEURYSM FROM THE CIRCULATION. TWO OF THE MOST WIDELY UTILIZED ENDOPROSTHESES ARE THE ENDURANT (MEDTRONIC VASCULAR INC, DUBLIN, IRELAND) AND ZENITH (COOK MEDICAL ZENITH FLEX), WHOSE MECHANISM OF PROXIMAL AORTA FIXATION ARE SUPRARENAL IN BOTH DEVICES. THEREFORE, THE IMPACT OF ENDOGRAFT SELECTION ON OUTCOMES FOLLOWING EVAR OF AAA IS CRUCIAL FOR PROPER SUCCESSFULLY RESULTS, MAINLY TO PREVENT ENDOLEAKS, LIMB GRAFT OCCLUSIONS AND REINTERVENTIONS. FACTORS SUCH AS STENT MIGRATION, LIMB GRAFT OCCLUSION, OR ENDOLEAKS SEEM TO BE THE MOST CULPABLE AGENTS THAT CAUSE POOR PROGNOSIS, WITH THE DEVELOPMENT OF SUBSEQUENT ANEURYSM PRESSURIZATION AND RUPTURE. THE ENDURANT STENT GRAFT IS DESIGNED TO TREAT STANDARD AAA ANATOMIES AND ADDRESS THE LIMITATIONS OF PREVIOUS DEVICES BY CONFORMING TO COMPLEX ANATOMIC AORTIC VARIATIONS, SUCH AS AORTIC TORTUOSITY AND ANGULATION. THE DEVICE INDICATIONS FOR USE (IFU) INCLUDE PATIENTS WITH A PROXIMAL NECK 10 MM OR LARGER WITH AN INFRARENAL NECK ANGULATION OF 60 DEGREES OR LESS OR A PROXIMAL NECK OF 15 MM OR GREATER WITH AN INFRARENAL NECK ANGULATION OF 75 DEGREES OR LESS. FURTHERMORE. THE ZENITH FLEX STENT GRAFT IFU INCLUDE PATIENTS WITH LENGTH =15 MM, NONANEURYSMAL INFRARENAL NECK, AORTIC FIXATION SITE DIAMETER 18 TO 32 MM (MEASURED OUTER WALL TO OUTER WALL), ANGLE <60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM AND HAS SPECIFIC LOW-PROFILE INTRODUCER SHEATHS. DESPITE THE LONG-TERM USE AND DEDICATED PAPERS REGARDING OUTCOMES IN THE OVERALL LITERATURE, THERE ARE VERY FEW STUDIES COMPARING THOSE TWO DEVICES REGARDING ENDOLEAKS, REINTERVENTIONS, AND DEATH RELATED TO ANEURYSM COMPLICATIONS (DETAILS IN TABLE 1). THEREFORE, THE MAIN OBJECTIVE OF THIS PAPER IS TO COMPARE THE OUTCOMES REGARDING ENDOLEAKS, REINTERVENTIONS, PERIOPERATIVE MORTALITY RATE, OVERALL SURVIVAL RATE, AND TIME FREEDOM FROM REINTERVENTION IN PATIENTS SUBMITTED TO EVAR FOR AAA USING ENDURANT STENT GRAFT (MEDTRONIC) AND ZENITH FLEX (COOK). MATERIALS AND METHODS: PATIENT INFORMED CONSENT WAS OBTAINED FOR THE STUDY ACCORDING TO THE HELSINKI DECLARATION FORM. THIS STUDY WAS APPROVED BY RESEARCH ETHICS COMMITTEE. THIS WAS A PROSPECTIVE, CONSECUTIVE COHORT STUDY OF PATIENTS WITH AAA WHO UNDERWENT EVAR AT THE DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY, BETWEEN (B)(6) 2019 AND (B)(6) 2022. PATIENT DATA WERE COLLECTED FROM THE VASCULAR SURGERY SERVICE DATABASE AND HOSPITAL RECORDS. THE ENZEN TRIAL WAS REGISTERED AT CLINICALTRIALS.GOV UNDER [FULL REGISTRATION NUMBER DETAILS OMITTED FOR DOUBLE-ANONYMIZED PEER REVIEW] REGISTRATION NUMBER. PATIENTS WITH AAA WHO HAD UNDERGONE EVAR WERE THE MAIN INCLUSION CRITERIA. THE MAIN EXCLUSION CRITERIA WERE PATIENTS WITH THORACOABDOMINAL, PARARENAL, SUPRARENAL AORTIC ANEURYSMS, AND PATIENTS NOT SUITABLE FOR EVAR, SUCH AS SIGNIFICANT NECK THROMBUS AND IMPORTANT NECK ANGULATION. PATIENTS WITH SUITABLE AORTIC ANATOMY AND HIGH CARDIAC RISK WERE SCHEDULED TO UNDERGO ENDOVASCULAR REPAIR. INDICATION FOR ANEURYSM SURGERY WAS EITHER AN AAA DIAMETER LARGER THAN 55 MM OR A COMMON ILIAC ARTERY DIAMETER LARGER THAN 30 MM. ENDOVASCULAR REPAIR WAS PERFORMED WITH USE OF AORTOILIAC ENDOGRAFTS. ALL PATIENTS WERE TRANSFERRED TO THE INTENSIVE CARE UNIT AFTER SURGERY, FOR AT LEAST 24 HOURS, BEFORE BEING TRANSFERRED TO THE NURSERY UNIT. ALL COMPUTED TOMOGRAPHY (CT) SCAN ANGIOGRAMS WERE EVALUATED ON THE HOROS (BASED UPON OSIRIXTM) SOFTWARE BY TWO ENDOVASCULAR SURGERIES TRAINED IN PLANNING AND SIZING OF STANDARD AND COMPLEX EVAR CASES. THE COMPUTED TOMOGRAPHY ANGIOGRAPHIES (CTAS) WERE EVALUATED ACCORDING TO GHATWARY ET AL. A CENTERLINE OF FLOW RECONSTRUCTION USING A SEMIAUTOMATED CENTERLINE ALGORITHM WAS GENERATED TO ASSESS AORTIC AND ILIAC MORPHOLOGIES. THE PREOPERATIVE ANEURYSMAL SAC THROMBUS LOAD WAS EVALUATED BY MEASURING THE FOLLOWING PARAMETERS ON THE CROSS-SECTIONAL CT IMAGES WITH THE WIDEST ANEURYSMAL DIAMETER (ZONE B): MAXIMUM THROMBUS THICKNESS (MTT), ALONG THE SHORTEST DIAGONAL, AND THE PERCENTAGE OF THROMBUS-LINED ANEURYSM CIRCUMFERENCE (TLAC). TLAC PERCENTAGE WAS DONE IN THE FOLLOWING REGIONS: AAA NECK, ZONE A (BETWEEN NECK AND ZONE B), AND ZONE C (BETWEEN ZONE B AND AORTIC BIFURCATION). TWO GROUPS OF PATIENTS WERE EVALUATED: GROUP ENDURANT (PATIENTS SUBMITTED TO EVAR WITH THE USE OF ENDURANT II STENT GRAFT) AND GROUP ZENITH (PATIENTS SUBMITTED TO EVAR WITH THE USE OF ZENITH FLEX ENDOGRAFT). THE CHOICE OF THE SPECIFIC ENDOGRAFT WAS BASED IN ANATOMIC CRITERIA: NECK LENGTH >10 MM FOR ENDURANT II OR >15 MM FOR ZENITH FLEX. IN PATIENTS WITH TORTUOUS ILIAC AND AORTIC NECK THERE WAS A PREFERENCE FOR ENDURANT II USAGE, SINCE IT SEEMS TO NAVIGATE BETTER IN TORTUOUS VESSELS. THE SURGEON PREFERENCE WAS A CRITERIUM ONCE THE IFU FOR EACH PROSTHESIS WAS RESPECTED. ALL OF THE PATIENTS WERE SCHEDULED FOR FOLLOW-UP AT THE HOSPITAL AT AND AT 1, 6, AND 12 MONTHS AFTER DISCHARGE. AFTER THE FIRST YEAR, THE PATIENTS WERE FOLLOWED UP EVERY 6 MONTHS, AND AFTER THE SECOND YEAR, EVERY 12 MONTHS, AT WHICH TIME THE FOLLOWING CLINICAL CRITERIA WERE EVALUATED: CLINICAL EXAMINATION, CT SCAN AND DOPPLER ULTRASONOGRAPHY. THE FIRST CT ANGIOGRAM WAS PERFORMED AT 1 MONTH AFTER THE SURGERY. TECHNICAL SUCCESS RATE AND EARLY OR LATE COMPLICATIONS WERE REPORTED ACCORDING TO REPORTING STANDARDS OF THE AD HOC COMMITTEE FOR STANDARDIZED REPORTING PRACTICES IN VASCULAR SURGERY/INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY. STATISTICAL ANALYSES WERE PERFORMED USING SPSS 21.0 FOR MAC. FREQUENCIES AND DESCRIPTIVE STATISTICS WERE ANALYZED. THE CHI-SQUARE TEST AND THE STUDENT T TEST WERE USED TO COMPARE THE UNIVARIATE ANALYSIS DATA. SURVIVAL CURVES TO ESTIMATE LIMB SALVAGE AND SURVIVAL RATES WERE CONSTRUCTED USING THE KAPLAN¿MEIER METHOD. A P VALUE <0.05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. THE MANN¿WHITNEY AND WILCOXON TESTS WERE USED AS NONPARAMETRIC TESTS. LINEAR REGRESSIONS WERE PERFORMED. THE ANALYSES WERE PERFORMED WITHIN 360 AND 720 DAYS OF THE PROCEDURE. DEFINITIONS AND STUDY END POINTS THE SUCCESSFUL DELIVERY AND DEPLOYMENT OF THE STENT GRAFT IN THE PLANNED LOCATION WITH NO UNINTENTIONAL COVERAGE OF EITHER INTERNAL ILIAC ARTERIES OR ANY VISCERAL AORTIC BRANCHES WAS DEFINED AS TECHNICAL SUCCESS. TECHNICAL SUCCESS WAS ALSO DEFINED AS NO ENDOLEAKS IDENTIFIED AND SUCCESSFUL DEPLOYMENT OF THE ENDOGRAFTS IMMEDIATELY AT THE END OF SURGERY. THE PRIMARY OUTCOME MEASURE OF TREATMENT SUCCESS WAS DEFINED AS TECHNICAL SUCCESS, ENDOLEAKS, REINTERVENTIONS, PERIOPERATIVE MORTALITY RATE, OVERALL SURVIVAL RATE, TIME FREEDOM FROM REINTERVENTION, AND STENT GRAFT LIMB OCCLUSION THROUGH 720 DAYS. MOREOVER, WE PERFORMED A SUBANALYSIS REGARDING CLINICALLY RELEVANT ENDOLEAKS (IA/B, III OR II OR REQUIRING REINTERVENTION). SECONDARY OUTCOME MEASURES INCLUDED STENT GRAFT PATENCY, SECONDARY PROCEDURES, MAJOR ADVERSE EFFECTS, COMPLICATIONS, ALL-CAUSE MORTALITY, AND TECHNICAL OBSERVATIONS. RESULTS: A TOTAL OF 300 PATIENTS WERE SUBMITTED TO AORTOILIAC ANEURYSM REPAIR, 70 PATIENTS UNDERWENT OPEN SURGERY REPAIR, 10 PATIENTS UNDERWENT EVAR REPAIR WITH GORE EXCLUDER REPAIR, AND THE OTHER 64 PATIENTS WERE EXCLUDED OF THE STUDY DUE TO BREACHED IFUS. THEREFORE, 156 PATIENTS WERE SUBMITTED TO EVAR BETWEEN JANUARY 2019 AND DECEMBER 2022 AND ALL OF THEM RESPECTED IFU INDICATIONS, WITH NO DIFFERENCE AMONG THE GROUPS. THE MEAN CLINICAL FOLLOW-UP PERIOD WAS 760 +/- 80 DAYS. ANALYSES WERE PERFORMED AT 720 DAYS. THERE WERE EVALUATED TWO GROUPS OF PATIENTS: ZENITH GROUP (67 PATIENTS, 42.9%) AND ENDURANT GROUP (89 PATIENTS, 57.1%). THE CLINICAL CHARACTERISTICS WERE SIMILAR BETWEEN THE TWO GROUPS. THE MEAN AGE IN THE TOTAL COHORT WAS 73.04 YEARS. THE DISEASE MORE PREVALENT IN THE TOTAL COHORT WAS ARTERIAL HYPERTENSION (81.4%), FOLLOWED BY SMOKING (42.3%), DIABETES (36.5%), AND CARDIAC DISEASE (26.3%). THE PERIOPERATIVE MORTALITY RATE WAS 5.1%, 8 PATIENTS (6 PATIENTS ZENITH GROUP AND 2 PATIENTS ENDURANT GROUP, P=0.054). THE PERIOPERATIVE MORTALITY RATE (PMR) IN PATIENTS WITH URGENT SURGERIES WAS 7.1% AND IN PATIENTS WITH ELECTIVE SURGERY WAS 3.8% (P=0.043). THERE WERE 28 PATIENTS (17.9%) SUBMITTED TO URGENT REPAIR OF THE ANEURYSM (EXPANSION OR RUPTURE), WITH NO DIFFERENCES AMONG THE GROUPS. ABOUT 68.6% OF THE PATIENTS PRESENTED WITH A MODERATE CARDIAC RISK, WITH NO DIFFERENCES AMONG THE GROUPS. THE OVERSIZING SEAL ZONES BY 10% TO 25% WAS USED IN BOTH GROUPS, WITH NO STATISTICAL DIFFERENCES. ALL THESE DATA ARE SUMMARIZED IN TABLE 2. REGARDING THE INDICATION FOR ANEURYSM REPAIR, MOST OF THEM WERE RELATED TO ANEURYSM DIAMETER (TOTAL 75.6%, ZENITH GROUP 76.1% AND ENDURANT GROUP 75.3% P=0.52). THERE WAS ONE CASE OF BLUE TOE SYNDROME (ENDURANT GROUP). AMONG THE TYPES OF ANEURYSMS, MOST PATIENTS HAD AORTOILIAC ANEURYSMS (92.9%, ZENITH GROUP 89.6%, ENDURANT GROUP 95.5%, P=0.32), FOLLOWED BY COMMON ILIAC ARTERY (TOTAL 4.5%, ZENITH 3.8% AND ENDURANT GROUP 0.6%, P=0.052), AND INFRARENAL AORTIC ANEURYSM (TOTAL 2.6%, ZENITH GROUP 0.6% AND ENDURANT GROUP 1.9%, P=0.49). THESE DATA ARE SUMMARIZED IN TABLE 3. THERE WERE 36 CASES (23.1%) OF LATER ENDOLEAKS, WITH A HIGHER INCIDENCE IN ZENITH GROUP (23 PATIENTS, 34.3%) THAN ENDURANT GROUP (13 PATIENTS, 14.6%, P=0.002), MOST OF THEM TYPE II ENDOLEAK (21 PATIENTS, 13.4%), HIGHER IN ZENITH GROUP (16.4%) THAN ENDURANT GROUP (11.2%, P=0.02). THERE WERE 12 CASES OF TYPE I ENDOLEAK, ALSO WITH A HIGHER PREVALENCE IN ZENITH GROUP (13.4%) THAN ENDURANT GROUP (3.4%, P=0.002). THERE WERE THREE CASES OF ENDOLEAK TYPE III, ALL OF THEM IN ZENITH GROUP. FURTHERMORE, THERE WERE 17 PATIENTS (10.9%) WITH CLINICALLY RELEVANT ENDOLEAKS (1A/B, III OR II OR REQUIRING REINTERVENTION) IN TOTAL COHORT. THE PREVALENCE OF CLINICALLY RELEVANT ENDOLEAKS WAS HIGHER IN ZENITH GROUP THAN ENDURANT GROUP (20.9% VS 3.4%, P=0.001). THERE WERE NO IMMEDIATE ENDOLEAKS. THE NUMBER OF PATENT INFERIOR MESENTERIC ARTERY AND NUMBER OF COUPLES OF PATENT LARGE LUMBAR ARTERIES WERE STATISTICALLY SIMILAR AMONG BOTH GROUPS. MOREOVER, REGARDING LIMB GRAFT OCCLUSION (LGO), THERE WERE NINE PATIENTS (5.8%) IN TOTAL COHORT, WITH A HIGHER PREVALENCE IN ZENITH GROUP (9%) THAN ENDURANT GROUP (3.4%, P=0.045). ALL PATIENTS WITH LGO HAD ENDOGRAFT DISTAL LAND ZONES AT EXTERNAL ILIAC ARTERY. THERE WERE SIX PATIENTS WITH LGO THAT ALSO HAD TORTUOUS ILIAC ARTERIES, WITH NO DIFFERENCES AMONG GROUPS. THERE WERE 27 PATIENTS (17.4%) SUBMITTED TO REINTERVENTION, WITH A HIGHER PREVALENCE IN ZENITH GROUP (19 PATIENTS, 12.3%) THAN ENDURANT GROUP (5.2%, P=0.001). REGARDING THE REINTERVENTIONS THERE WERE TWO CASES OF COIL EMBOLIZATION IN THE HYPOGASTRIC ARTERY ASSOCIATED TO GLUE EMBOLIZATION WITH ÔNIX, ONE CASE OF PROXIMAL EXTENSION WITH AN AORTIC CUFF CLOSE TO RENAL ARTERIES, ONE CASE OF SNORKEL FOR LEFT RENAL ARTERY WITH AORTIC PROXIMAL CUFF, NINE CASES OF PHARMACOMECHANICAL THROMBECTOMY WITH ANGIOJET WITH STENT DEPLOYMENT DUE TO LIMB GRAFT OCCLUSION, TWO CASES WITH ZBIS DEPLOYMENT DUE TO IB ENDOLEAK, TWO CASES OF LATE OPEN CONVERSION DUE TO ENDOLEAK, TWO CASES OF OPEN SURGERY TO BOWEL RESECTION DUE TO BOWEL ISCHEMIA, THREE CASES OF PERCUTANEOUS DRAINAGE OF PERIPROSTHESIS COLLECTION DUE TO PREVIOUS ENDOVASCULAR CORRECTION OF AORTIC RUPTURE AND SIX CASES OF HYPOGASTRIC ARTERY (HA) EMBOLIZATION WITH DISTAL IMPLANT OF ENDOVASCULAR EXTENSIONS DUE TO ENDOLEAK IB. THESE DATA ARE SUMMARIZED IN TABLE 3. A TOTAL OF 69 PATIENTS WERE SUBMITTED TO EVAR ASSOCIATED WITH CONCOMITANT HA EMBOLIZATION WITH COILS (ZENITH GROUP 37.3% AND ENDURANT GROUP 49.4%, P=0.089). THERE WERE 19 PATIENTS SUBMITTED TO ZENITH BIFURCATED ILIAC SIDE ZBIS (COOK MEDICAL), WITH A HIGHER INCIDENCE IN ZENITH GROUP 26.9% ALTHOUGH ENDURANT GROUP HAD 1.1%, P<0.001. A TOTAL OF 21 PATIENTS WERE SUBMITTED TO BELL BOTTOM IMPLANTS IN COMMON ILIAC ARTERIES, WITH NO DIFFERENCES AMONG BOTH GROUPS (GROUP ZENITH 10.4% AND ENDURANT GROUP 15.7%, P=0.35). THOSE PATIENTS SUBMITTED TO ZBIS AND BELL BOTTOM WERE EVALUATED IN FOLLOW-UP, WITHOUT COMPLICATIONS AND ENDOLEAKS. REGARDING THE PATENCY OF THE HA, BEFORE SURGERY 95.5% OF THE PATIENTS HAD BILATERAL PATENCY OF HA, HOWEVER, AFTER SURGERY 96.8% OF THE PATIENTS HAD AT LEAST ONE HA PATENT. THE MEAN DIAMETERS OF THE AORTOILIAC ANEURYSMS WERE LENGTH OF AORTIC NECK 20.00 MM, (ZENITH GROUP 19.88 MM VS ENDURANT GROUP 18.34 MM, P=0.75), DIAMETER OF AORTIC ANEURYSM 71.66 +/- 22.6 MM (ZENITH GROUP 70.68 =/- 21.7 MM, ENDURANT GROUP 72.67 =/- 20.7 MM, P=0.92), RIGHT COMMON ILIAC ARTERY 14 =/- 10.1(ZENITH GROUP 13.68 =/-11.7 MM, ENDURANT GROUP 14.68 =/- 10.7 =/- 10.7 MM, P=0.93), LEFT COMMON ILIAC ARTERY 18.03 =/- 10.3 MM (ZENITH GROUP 18.58 =/- 10.2 MM, ENDURANT GROUP 17.68 =/-10.1 MM, P=0.91), RIGHT EXTERNAL ILIAC DIAMETER 13.40 =/-0.8 MM (ZENITH GROUP 13.68 =/-10.7 MM, ENDURANT GROUP 13.58 +/- 11. 7 MM, P=0.92), LEFT EXTERNAL ILIAC DIAMETER 10.81 +/- 0.6 MM (ZENITH GROUP 10.68 =/-2.7 MM, ENDURANT GROUP 10.67 =/- 1.7 MM, P=0.94) RIGHT INTERNAL ILIAC DIAMETER 15.77 =/-10.2 MM (ZENITH GROUP 13.68 =/-1.7 MM, ENDURANT GROUP 15.69 =/-1.8 MM, P=0.93), NECK DIAMETER 22.00 =/- 7.6 MM (ZENITH GROUP 21.16 =/- 6.8 MM, ENDURANT GROUP 22.10 =/-6.7 MM, P=0.48) AND LEFT INTERNAL ILIAC DIAMETER 16.50 =/-5.6 MM (ZENITH GROUP 17.68 =/- 5.7 MM, ENDURANT GROUP 16.68 =/- 16.7 MM, P=0.95). (TABLE 3). REGARDING THE DISTAL LANDING ZONE, THE ILIAC COMMON ARTERY WAS THE MOST COMMON WITH 243 LIMBS, WITHOUT STATISTICAL SIGNIFICANCE AMONG THE GROUPS. MOREOVER, THE ILIAC SEAL ZONE LENGTH WAS 34 MM, AND THE ILIAC SEAL ZONE DIAMETER WAS 16.63 MM, WITH NO DIFFERENCES AMONG THE GROUPS. THESE DATA ARE SUMMARIZED IN TABLE 4. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN PREOPERATIVE MTT AND THE INCIDENCE OF LATE ENDOLEAKS IN ALL LOCATIONS. TABLE 5 SUMMARIZES THE CORRELATION OF PREOPERATIVE THROMBUS LOAD ACCORDING TO ZONES AND THE INCIDENCE OF ENDOLEAKS. WE PERFORMED A UNIVARIATE AND MULTIVARIATE LINEAR REGRESSION ANALYSIS TO IDENTIFY FACTORS RELATED TO SURVIVAL RATE (TABLE 6). THE LINEAR REGRESSION ANALYSIS FOR SURVIVAL RATES SHOWED THAT CHRONIC KIDNEY DISEASE (P=0.03; HAZARD RATIO [HR]=2.82, CI=1.07¿4.44), WAS THE ONLY FACTOR RELATED TO POORER SURVIVAL RATES IN BOTH UNIVARIATE AND MULTIVARIATE ANALYSIS. A UNIVARIATE AND MULTIVARIATE LINEAR REGRESSION ANALYSIS WAS PERFORMED TO IDENTIFY FACTORS RELATED TO REINTERVENTION (TABLE 7). THE LINEAR REGRESSION ANALYSIS SHOWED THAT THE PRESENCE OF ENDOLEAKS (P<0.001, HR=6.69, CI=2.26¿8.48), TYPE OF ENDOGRAFT DEVICE (ZENITH GRAFT) (P=0.003, HR=2.213, CI=1.140¿3.943) AND LIMB GRAFT OCCLUSION (P<0.001, HR=8.02, CI=1.60¿9.99) WERE RELATED TO REINTERVENTION IN BOTH UNIVARIATE AND MULTIVARIATE ANALYSIS. THE OVERALL SURVIVAL IN A KAPLAN¿MEIER AT 720 DAYS WAS82.3% IN THE ZENITH GROUP AND 89.1% IN THE ENDURANT GROUP, WITH NO STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P=0.09) (FIGURE 1). REGARDING ANEURYSM-RELATED MORTALITY, THERE WERE 28 CASES (17.9%) IN TOTAL COHORT GLOBALLY, WITH HIGHER INCIDENCE AT ZENITH GROUP (17 CASES; 25,4%) THAN ENDURANT GROUP (11 CASES, 12.4%), P=0.03. THE FREEDOM FROM REINTERVENTION RATES IN A KAPLAN¿MEIER AT 720 DAYS WAS 82.8% IN THE ZENITH GROUP AND 93.2% IN THE ENDURANT GROUP, WITH STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P=0.001) (FIGURE 2). ALL ENDOLEAKS PREVALENCE IN A KAPLAN¿MEIER AT 720 DAYS WAS 34.3% IN THE ZENITH GROUP AND 14.6% IN THE ENDURANT GROUP, WITH STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P<0.001) WITH HIGHER RATES IN THE ZENITH GROUP (FIGURE 3). REFERENCE DE ATHAYDE SOARES, R., PORTELA, M. V., AMARO, K., NASSER, A. I., PEDROSA, K. DE, & SACILOTTO, R. (2024). THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS. JOURNAL OF ENDOVASCULAR THERAPY. HTTPS://DOI.ORG/10.1177/15266028241270895. THE FOCUS OF THIS REPORT IS THE FOUR DEVICES WITH TYPE IB ENDOLEAKS ON AN UNKNOWN ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AND REQUIRED ZENITH BRANCH ENDOVASCULAR GRAFT- ILIAC BIFURCATION PLACEMENTS AND/OR HYPOGASTRIC EMBOLIZATION. REVIEWS OF DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU), DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. MEDICAL IMAGING WAS NOT PROVIDED FOR REVIEW. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. IT SHOULD BE NOTED THAT THIS DEVICE IS SUPPLIED VIA A ONE-DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. IFU T_ZAAASZ_REV4 WAS REVIEWED FOR THIS COMPLAINT. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. 4 WARNINGS AND PRECAUTIONS 4.1 GENERAL ¿ PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ¿ PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20 MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ADDITIONALLY, THE COMPLETION ANGIOGRAM (WITH STIFF WIRE GUIDES REMOVED) SHOULD BE REVIEWED CAREFULLY TO DETERMINE IF FURTHER TREATMENT IN THESE REGIONS IS NECESSARY (E.G., ADJUNCTIVE BALLOONING OR STENTING). FAILURE TO REMOVE THE STIFF WIRE GUIDE PRIOR TO THE ANGIOGRAM COULD MASK ANY LIMB KINKING OR NARROWING THAT MIGHT OCCUR WHEN THE WIRE GUIDE IS REMOVED. ¿ FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5 MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). REINTERVENTION (E.G., NONCOMPLIANT BALLOONING OR STENTING IN THESE REGIONS) SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ¿ PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. ¿ SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION 4.3, PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING ¿ CLINICAL EXPERIENCE INDICATES THAT CONTRAST-ENHANCED SPIRAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) WITH 3-D RECONSTRUCTION IS THE STRONGLY RECOMMENDED IMAGING MODALITY TO ACCURATELY ASSESS PATIENT ANATOMY PRIOR TO TREATMENT WITH THE ZENITH SPIRAL-Z AAA ILIAC LEG. IF CONTRAST-ENHANCED SPIRAL CTA WITH 3-D RECONSTRUCTION IS NOT AVAILABLE, THE PATIENT SHOULD BE REFERRED TO A FACILITY WITH THESE CAPABILITIES. LENGTHS ¿ ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAK, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. ¿ AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED, INCLUDING: 1) ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (SEPARATION BETWEEN COMPONENTS OR STENT FRACTURE) AND 2) CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. 4.4 DEVICE SELECTION ¿ STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLE 10.5.1). APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. 4.5 IMPLANT PROCEDURE ¿ DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF RESISTANCE; VESSEL, CATHETER OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS, OR IN CALCIFIED OR TORTUOUS VESSELS. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. ¿ FLUOROSCOPY SHOULD BE USED DURING INTRODUCTION AND DEPLOYMENT TO CONFIRM PROPER OPERATION OF THE DELIVERY SYSTEM COMPONENTS, PROPER PLACEMENT OF THE GRAFT, AND DESIRED PROCEDURAL OUTCOME. ¿ EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. 5.2 POTENTIAL ADVERSE EVENTS ¿ CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; AND CORROSION ¿ GRAFT OR NATIVE VESSEL OCCLUSION ¿ SURGICAL CONVERSION TO OPEN REPAIR 7.1 INDIVIDUALIZATION OF TREATMENT ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ PATIENT¿S AGE AND LIFE EXPECTANCY ¿ CO-MORBIDITIES (E.G., CARDIAC, PULMONARY, OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY) ¿ PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR ¿ PATIENT¿S ABILITY TO TOLERATE GENERAL, REGIONAL, OR LOCAL ANESTHESIA. ¿ ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. ¿ FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT. 8 PATIENT COUNSELING INFORMATION ¿ ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. ¿ PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS A CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAAS. AT A MINIMUM, ANNUAL IMAGING AND ADHERENCE TO ROUTINE POSTOPERATIVE FOLLOW-UP REQUIREMENTS IS REQUIRED AND SHOULD BE CONSIDERED A LIFE-LONG COMMITMENT TO THE PATIENT¿S HEALTH AND WELL-BEING. ¿ PHYSICIANS MUST ADVISE ALL PATIENTS THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG. ANEURYSM RUPTURE MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: PAIN; NUMBNESS; WEAKNESS IN THE LEGS; ANY BACK, CHEST, ABDOMINAL OR GROIN PAIN; DIZZINESS; FAINTING; RAPID HEARTBEAT OR SUDDEN WEAKNESS. PHYSICIANS SHOULD REFER PATIENTS TO THE PATIENT GUIDE REGARDING RISKS OCCURRING DURING OR AFTER IMPLANTATION OF THE DEVICE. PROCEDURE-RELATED RISKS INCLUDE CARDIAC, PULMONARY, NEUROLOGIC, BOWEL AND BLEEDING COMPLICATIONS. DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE AND DEATH (SEE SECTION 5.1, OBSERVED ADVERSE EVENTS AND SECTION 5.2, POTENTIAL ADVERSE EVENTS). THE PHYSICIAN SHOULD COMPLETE THE PATIENT I.D. CARD AND GIVE IT TO THE PATIENT SO THAT HE/SHE CAN CARRY IT WITH HIM/HER AT ALL TIMES. THE PATIENT SHOULD REFER TO THE CARD ANYTIME HE/SHE VISITS ADDITIONAL HEALTH PRACTITIONERS, PARTICULARLY FOR ANY ADDITIONAL DIAGNOSTIC PROCEDURES (E.G., MRI). 11 DIRECTIONS FOR USE ¿ ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES. ARTERIAL CONDUIT TECHNIQUES MAY BE REQUIRED. 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 12.1 GENERAL ¿ THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS WITH SECONDARY ENDOVASCULAR INTERVENTION USING ADDITIONAL COMPONENTS HAS NOT YET BEEN ESTABLISHED. ¿ ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. ¿ PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS A CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAAS. ¿ PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASIS AND PRESCRIBE FOLLOW-UP RELATIVE TO THE NEEDS AND CIRCUMSTANCES OF EACH INDIVIDUAL PATIENT. THE MINIMUM REQUIREMENT FOR PATIENT FOLLOW-UP (DESCRIBED IN THE INSTRUCTIONS FOR USE FOR THE ZENITH AAA DEVICE THAT WAS USED) SHOULD BE MAINTAINED EVEN IN THE ABSENCE OF CLINICAL SYMPTOMS (E.G., PAIN, NUMBNESS, WEAKNESS). PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE STENT GRAFT) SHOULD RECEIVE FOLLOW-UP AT MORE FREQUENT INTERVALS. ¿ THE COMBINATION OF CONTRAST AND NON-CONTRAST CT IMAGING PROVIDES INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, PROGRESSIVE DISEASE, FIXATION LENGTH AND OTHER MORPHOLOGICAL CHANGES. ¿ DUPLEX ULTRASOUND IMAGING MAY PROVIDE INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE. AFTER REVIEW OF THE IFU, COOK HAS CONCLUDED THE DEVICE LABELING CONTAINS APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS TO THE USER RELATED TO THE REPORTED FAILURE. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT OR MEDICAL IMAGING, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - JAN2009 - 08FEB2025. D6A - IMPLANT DATE - (B)(6) 2019 - (B)(6) 2022. H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    CORRECTION TO INITIAL EVENT DESCRIPTION: FOUR DEVICES HAD TYPE 1B ENDOLEAKS RATHER THAN FOUR PATIENTS.

    Description of Event or Problem · 0

    COOK WAS INFORMED OF FOUR PATIENTS WITH TYPE IB ENDOLEAKS ON AN UNKNOWN ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THIS WAS PRESENTED IN THE ARTICLE ¿THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS¿ IN THE JOURNAL OF ENDOVASCULAR THERAPY. INTRODUCTION ENDOVASCULAR AORTIC REPAIR (EVAR) OF INFRARENAL ABDOMINAL AORTOILIAC ANEURYSMS (AAA) HAS EMERGED AS A LESS INVASIVE AND PREFERABLE MODALITY OF TREATMENT THAN OPEN SURGERY IN THE PAST YEARS, WITH SATISFACTORY, RELIABLE RESULTS, AND BOTH TECHNIQUES ACHIEVING A SIGNIFICANT REDUCTION IN SHORT- AND LONG-TERM MORTALITY.1 HOWEVER, EVAR HAS RELATIVELY LOW PERIOPERATIVE COMPLICATION RATE, WHICH IS RESPONSIBLE FOR THE INCREASING USE OF THE ENDOGRAFTS IN ALL SUITABLE PATIENTS, PARTICULARLY THOSE WITH AN INCREASED SURGICAL RISK. THERE ARE SEVERAL ENDOGRAFTS AVAILABLE FOR EVAR OF AAA, WITH DIFFERENT PROSTHETIC MATERIAL COVERING THE METAL FRAMEWORK OF ENDOGRAFTS AND DIFFERENT MECHANISMS OF AORTA FIXATION (INFRARENAL, SUPRARENAL), AIMING TO EXCLUDE THE ANEURYSM FROM THE CIRCULATION. TWO OF THE MOST WIDELY UTILIZED ENDOPROSTHESES ARE THE ENDURANT (MEDTRONIC VASCULAR INC, DUBLIN, IRELAND) AND ZENITH (COOK MEDICAL ZENITH FLEX), WHOSE MECHANISM OF PROXIMAL AORTA FIXATION ARE SUPRARENAL IN BOTH DEVICES. THEREFORE, THE IMPACT OF ENDOGRAFT SELECTION ON OUTCOMES FOLLOWING EVAR OF AAA IS CRUCIAL FOR PROPER SUCCESSFULLY RESULTS, MAINLY TO PREVENT ENDOLEAKS, LIMB GRAFT OCCLUSIONS AND REINTERVENTIONS. FACTORS SUCH AS STENT MIGRATION, LIMB GRAFT OCCLUSION, OR ENDOLEAKS SEEM TO BE THE MOST CULPABLE AGENTS THAT CAUSE POOR PROGNOSIS, WITH THE DEVELOPMENT OF SUBSEQUENT ANEURYSM PRESSURIZATION AND RUPTURE. THE ENDURANT STENT GRAFT IS DESIGNED TO TREAT STANDARD AAA ANATOMIES AND ADDRESS THE LIMITATIONS OF PREVIOUS DEVICES BY CONFORMING TO COMPLEX ANATOMIC AORTIC VARIATIONS, SUCH AS AORTIC TORTUOSITY AND ANGULATION.5 THE DEVICE INDICATIONS FOR USE (IFU) INCLUDE PATIENTS WITH A PROXIMAL NECK 10 MM OR LARGER WITH AN INFRARENAL NECK ANGULATION OF 60 DEGREES OR LESS OR A PROXIMAL NECK OF 15 MM OR GREATER WITH AN INFRARENAL NECK ANGULATION OF 75 DEGREES OR LESS. FURTHERMORE. THE ZENITH FLEX STENT GRAFT IFU INCLUDE PATIENTS WITH LENGTH =15 MM, NONANEURYSMAL INFRARENAL NECK, AORTIC FIXATION SITE DIAMETER 18 TO 32 MM (MEASURED OUTER WALL TO OUTER WALL), ANGLE <60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM AND HAS SPECIFIC LOW-PROFILE INTRODUCER SHEATHS. DESPITE THE LONG-TERM USE AND DEDICATED PAPERS REGARDING OUTCOMES IN THE OVERALL LITERATURE, THERE ARE VERY FEW STUDIES COMPARING THOSE TWO DEVICES REGARDING ENDOLEAKS, REINTERVENTIONS, AND DEATH RELATED TO ANEURYSM COMPLICATIONS (DETAILS IN TABLE 1). THEREFORE, THE MAIN OBJECTIVE OF THIS PAPER IS TO COMPARE THE OUTCOMES REGARDING ENDOLEAKS, REINTERVENTIONS, PERIOPERATIVE MORTALITY RATE, OVERALL SURVIVAL RATE, AND TIME FREEDOM FROM REINTERVENTION IN PATIENTS SUBMITTED TO EVAR FOR AAA USING ENDURANT STENT GRAFT (MEDTRONIC) AND ZENITH FLEX (COOK). MATERIALS AND METHODS PATIENT INFORMED CONSENT WAS OBTAINED FOR THE STUDY ACCORDING TO THE HELSINKI DECLARATION FORM. THIS STUDY WAS APPROVED BY RESEARCH ETHICS COMMITTEE. THIS WAS A PROSPECTIVE, CONSECUTIVE COHORT STUDY OF PATIENTS WITH AAA WHO UNDERWENT EVAR AT THE DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY, BETWEEN JANUARY 2019 AND DECEMBER 2022. PATIENT DATA WERE COLLECTED FROM THE VASCULAR SURGERY SERVICE DATABASE AND HOSPITAL RECORDS. THE ENZEN TRIAL WAS REGISTERED AT CLINICALTRIALS.GOV UNDER [FULL REGISTRATION NUMBER DETAILS OMITTED FOR DOUBLE-ANONYMIZED PEER REVIEW] REGISTRATION NUMBER. PATIENTS WITH AAA\ WHO HAD UNDERGONE EVAR WERE THE MAIN INCLUSION CRITERIA. THE MAIN EXCLUSION CRITERIA WERE PATIENTS WITH THORACOABDOMINAL, PARARENAL, SUPRARENAL AORTIC ANEURYSMS, AND PATIENTS NOT SUITABLE FOR EVAR, SUCH AS SIGNIFICANT NECK THROMBUS AND IMPORTANT NECK ANGULATION. PATIENTS WITH SUITABLE AORTIC ANATOMY AND HIGH CARDIAC RISK WERE SCHEDULED TO UNDERGO ENDOVASCULAR REPAIR. INDICATION FOR ANEURYSM SURGERY WAS EITHER AN AAA DIAMETER LARGER THAN 55 MM OR A COMMON ILIAC ARTERY DIAMETER LARGER THAN 30 MM. ENDOVASCULAR REPAIR WAS PERFORMED WITH USE OF AORTOILIAC ENDOGRAFTS. ALL PATIENTS WERE TRANSFERRED TO THE INTENSIVE CARE UNIT AFTER SURGERY, FOR AT LEAST 24 HOURS, BEFORE BEING TRANSFERRED TO THE NURSERY UNIT. ALL COMPUTED TOMOGRAPHY (CT) SCAN ANGIOGRAMS WERE EVALUATED ON THE HOROS (BASED UPON OSIRIXTM) SOFTWARE BY TWO ENDOVASCULAR SURGERIES TRAINED IN PLANNING AND SIZING OF STANDARD AND COMPLEX EVAR CASES. THE COMPUTED TOMOGRAPHY ANGIOGRAPHIES (CTAS) WERE EVALUATED ACCORDING TO GHATWARY ET AL. A CENTERLINE OF FLOW RECONSTRUCTION USING A SEMIAUTOMATED CENTERLINE ALGORITHM WAS GENERATED TO ASSESS AORTIC AND ILIAC MORPHOLOGIES. THE PREOPERATIVE ANEURYSMAL SAC THROMBUS LOAD WAS EVALUATED BY MEASURING THE FOLLOWING PARAMETERS ON THE CROSS-SECTIONAL CT IMAGES WITH THE WIDEST ANEURYSMAL DIAMETER (ZONE B): MAXIMUM THROMBUS THICKNESS (MTT), ALONG THE SHORTEST DIAGONAL, AND THE PERCENTAGE OF THROMBUS-LINED ANEURYSM CIRCUMFERENCE (TLAC). TLAC PERCENTAGE WAS DONE IN THE FOLLOWING REGIONS: AAA NECK, ZONE A (BETWEEN NECK AND ZONE B), AND ZONE C (BETWEEN ZONE B AND AORTIC BIFURCATION). TWO GROUPS OF PATIENTS WERE EVALUATED: GROUP ENDURANT (PATIENTS SUBMITTED TO EVAR WITH THE USE OF ENDURANT II STENT GRAFT) AND GROUP ZENITH (PATIENTS SUBMITTED TO EVAR WITH THE USE OF ZENITH FLEX ENDOGRAFT). THE CHOICE OF THE SPECIFIC ENDOGRAFT WAS BASED IN ANATOMIC CRITERIA: NECK LENGTH >10 MM FOR ENDURANT II OR >15 MM FOR ZENITH FLEX. IN PATIENTS WITH TORTUOUS ILIAC AND AORTIC NECK THERE WAS A PREFERENCE FOR ENDURANT II USAGE, SINCE IT SEEMS TO NAVIGATE BETTER IN TORTUOUS VESSELS. THE SURGEON PREFERENCE WAS A CRITERIUM ONCE THE IFU FOR EACH PROSTHESIS WAS RESPECTED. ALL OF THE PATIENTS WERE SCHEDULED FOR FOLLOW-UP AT THE HOSPITAL AT AND AT 1, 6, AND 12 MONTHS AFTER DISCHARGE. AFTER THE FIRST YEAR, THE PATIENTS WERE FOLLOWED UP EVERY 6 MONTHS, AND AFTER THE SECOND YEAR, EVERY 12 MONTHS, AT WHICH TIME THE FOLLOWING CLINICAL CRITERIA WERE EVALUATED: CLINICAL EXAMINATION, CT SCAN AND DOPPLER ULTRASONOGRAPHY. THE FIRST CT ANGIOGRAM WAS PERFORMED AT 1 MONTH AFTER THE SURGERY. TECHNICAL SUCCESS RATE AND EARLY OR LATE COMPLICATIONS WERE REPORTED ACCORDING TO REPORTING STANDARDS OF THE AD HOC COMMITTEE FOR STANDARDIZED REPORTING PRACTICES IN VASCULAR SURGERY/INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY. STATISTICAL ANALYSES WERE PERFORMED USING SPSS 21.0 FOR MAC. FREQUENCIES AND DESCRIPTIVE STATISTICS WERE ANALYZED. THE CHI-SQUARE TEST AND THE STUDENT T TEST WERE USED TO COMPARE THE UNIVARIATE ANALYSIS DATA. SURVIVAL CURVES TO ESTIMATE LIMB SALVAGE AND SURVIVAL RATES WERE CONSTRUCTED USING THE KAPLAN¿MEIER METHOD. A P VALUE <0.05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. THE MANN¿WHITNEY AND WILCOXON TESTS WERE USED AS NONPARAMETRIC TESTS. LINEAR REGRESSIONS WERE PERFORMED. THE ANALYSES WERE PERFORMED WITHIN 360 AND 720 DAYS OF THE PROCEDURE. DEFINITIONS AND STUDY END POINTS THE SUCCESSFUL DELIVERY AND DEPLOYMENT OF THE STENT GRAFT IN THE PLANNED LOCATION WITH NO UNINTENTIONAL COVERAGE OF EITHER INTERNAL ILIAC ARTERIES OR ANY VISCERAL AORTIC BRANCHES WAS DEFINED AS TECHNICAL SUCCESS. TECHNICAL SUCCESS WAS ALSO DEFINED AS NO ENDOLEAKS IDENTIFIED AND SUCCESSFUL DEPLOYMENT OF THE ENDOGRAFTS IMMEDIATELY AT THE END OF SURGERY. THE PRIMARY OUTCOME MEASURE OF TREATMENT SUCCESS WAS DEFINED AS TECHNICAL SUCCESS, ENDOLEAKS, REINTERVENTIONS, PERIOPERATIVE MORTALITY RATE, OVERALL SURVIVAL RATE, TIME FREEDOM FROM REINTERVENTION, AND STENT GRAFT LIMB OCCLUSION THROUGH 720 DAYS. MOREOVER, WE PERFORMED A SUBANALYSIS REGARDING CLINICALLY RELEVANT ENDOLEAKS (IA/B, III OR II OR REQUIRING REINTERVENTION). SECONDARY OUTCOME MEASURES INCLUDED STENT GRAFT PATENCY, SECONDARY PROCEDURES, MAJOR ADVERSE EFFECTS, COMPLICATIONS, ALL-CAUSE MORTALITY, AND TECHNICAL OBSERVATIONS. RESULTS A TOTAL OF 300 PATIENTS WERE SUBMITTED TO AORTOILIAC ANEURYSM REPAIR, 70 PATIENTS UNDERWENT OPEN SURGERY REPAIR, 10 PATIENTS UNDERWENT EVAR REPAIR WITH GORE EXCLUDER REPAIR, AND THE OTHER 64 PATIENTS WERE EXCLUDED OF THE STUDY DUE TO BREACHED IFUS. THEREFORE, 156 PATIENTS WERE SUBMITTED TO EVAR BETWEEN JANUARY 2019 AND DECEMBER 2022 AND ALL OF THEM RESPECTED IFU INDICATIONS, WITH NO DIFFERENCE AMONG THE GROUPS. THE MEAN CLINICAL FOLLOW-UP PERIOD WAS 760 +/- 80 DAYS. ANALYSES WERE PERFORMED AT 720 DAYS. THERE WERE EVALUATED TWO GROUPS OF PATIENTS: ZENITH GROUP (67 PATIENTS, 42.9%) AND ENDURANT GROUP (89 PATIENTS, 57.1%). THE CLINICAL CHARACTERISTICS WERE SIMILAR BETWEEN THE TWO GROUPS. THE MEAN AGE IN THE TOTAL COHORT WAS 73.04 YEARS. THE DISEASE MORE PREVALENT IN THE TOTAL COHORT WAS ARTERIAL HYPERTENSION (81.4%), FOLLOWED BY SMOKING (42.3%), DIABETES (36.5%), AND CARDIAC DISEASE (26.3%). THE PERIOPERATIVE MORTALITY RATE WAS 5.1%, 8 PATIENTS (6 PATIENTS ZENITH GROUP AND 2 PATIENTS ENDURANT GROUP, P=0.054). THE PERIOPERATIVE MORTALITY RATE (PMR) IN PATIENTS WITH URGENT SURGERIES WAS 7.1% AND IN PATIENTS WITH ELECTIVE SURGERY WAS 3.8% (P=0.043). THERE WERE 28 PATIENTS (17.9%) SUBMITTED TO URGENT REPAIR OF THE ANEURYSM (EXPANSION OR RUPTURE), WITH NO DIFFERENCES AMONG THE GROUPS. ABOUT 68.6% OF THE PATIENTS PRESENTED WITH A MODERATE CARDIAC RISK, WITH NO DIFFERENCES AMONG THE GROUPS. THE OVERSIZING SEAL ZONES BY 10% TO 25% WAS USED IN BOTH GROUPS, WITH NO STATISTICAL DIFFERENCES. ALL THESE DATA ARE SUMMARIZED IN TABLE 2. REGARDING THE INDICATION FOR ANEURYSM REPAIR, MOST OF THEM WERE RELATED TO ANEURYSM DIAMETER (TOTAL 75.6%, ZENITH GROUP 76.1% AND ENDURANT GROUP 75.3% P=0.52). THERE WAS ONE CASE OF BLUE TOE SYNDROME (ENDURANT GROUP). AMONG THE TYPES OF ANEURYSMS, MOST PATIENTS HAD AORTOILIAC ANEURYSMS (92.9%, ZENITH GROUP 89.6%, ENDURANT GROUP 95.5%, P=0.32), FOLLOWED BY COMMON ILIAC ARTERY (TOTAL 4.5%, ZENITH 3.8% AND ENDURANT GROUP 0.6%, P=0.052), AND INFRARENAL AORTIC ANEURYSM (TOTAL 2.6%, ZENITH GROUP 0.6% AND ENDURANT GROUP 1.9%, P=0.49). THESE DATA ARE SUMMARIZED IN TABLE 3. THERE WERE 36 CASES (23.1%) OF LATER ENDOLEAKS, WITH A HIGHER INCIDENCE IN ZENITH GROUP (23 PATIENTS, 34.3%) THAN ENDURANT GROUP (13 PATIENTS, 14.6%, P=0.002), MOST OF THEM TYPE II ENDOLEAK (21 PATIENTS, 13.4%), HIGHER IN ZENITH GROUP (16.4%) THAN ENDURANT GROUP (11.2%, P=0.02). THERE WERE 12 CASES OF TYPE I ENDOLEAK, ALSO WITH A HIGHER PREVALENCE IN ZENITH GROUP (13.4%) THAN ENDURANT GROUP (3.4%, P=0.002). THERE WERE THREE CASES OF ENDOLEAK TYPE III, ALL OF THEM IN ZENITH GROUP. FURTHERMORE, THERE WERE 17 PATIENTS (10.9%) WITH CLINICALLY RELEVANT ENDOLEAKS (1A/B, III OR II OR REQUIRING REINTERVENTION) IN TOTAL COHORT. THE PREVALENCE OF CLINICALLY RELEVANT ENDOLEAKS WAS HIGHER IN ZENITH GROUP THAN ENDURANT GROUP (20.9% VS 3.4%, P=0.001). THERE WERE NO IMMEDIATE ENDOLEAKS. THE NUMBER OF PATENT INFERIOR MESENTERIC ARTERY AND NUMBER OF COUPLES OF PATENT LARGE LUMBAR ARTERIES WERE STATISTICALLY SIMILAR AMONG BOTH GROUPS. MOREOVER, REGARDING LIMB GRAFT OCCLUSION (LGO), THERE WERE NINE PATIENTS (5.8%) IN TOTAL COHORT, WITH A HIGHER PREVALENCE IN ZENITH GROUP (9%) THAN ENDURANT GROUP (3.4%, P=0.045). ALL PATIENTS WITH LGO HAD ENDOGRAFT DISTAL LAND ZONES AT EXTERNAL ILIAC ARTERY. THERE WERE SIX PATIENTS WITH LGO THAT ALSO HAD TORTUOUS ILIAC ARTERIES, WITH NO DIFFERENCES AMONG GROUPS. THERE WERE 27 PATIENTS (17.4%) SUBMITTED TO REINTERVENTION, WITH A HIGHER PREVALENCE IN ZENITH GROUP (19 PATIENTS, 12.3%) THAN ENDURANT GROUP (5.2%, P=0.001). REGARDING THE REINTERVENTIONS THERE WERE TWO CASES OF COIL EMBOLIZATION IN THE HYPOGASTRIC ARTERY ASSOCIATED TO GLUE EMBOLIZATION WITH ÔNIX, ONE CASE OF PROXIMAL EXTENSION WITH AN AORTIC CUFF CLOSE TO RENAL ARTERIES, ONE CASE OF SNORKEL FOR LEFT RENAL ARTERY WITH AORTIC PROXIMAL CUFF, NINE CASES OF PHARMACOMECHANICAL THROMBECTOMY WITH ANGIOJET WITH STENT DEPLOYMENT DUE TO LIMB GRAFT OCCLUSION, TWO CASES WITH ZBIS DEPLOYMENT DUE TO IB ENDOLEAK, TWO CASES OF LATE OPEN CONVERSION DUE TO ENDOLEAK, TWO CASES OF OPEN SURGERY TO BOWEL RESECTION DUE TO BOWEL ISCHEMIA, THREE CASES OF PERCUTANEOUS DRAINAGE OF PERIPROSTHESIS COLLECTION DUE TO PREVIOUS ENDOVASCULAR CORRECTION OF AORTIC RUPTURE AND SIX CASES OF HYPOGASTRIC ARTERY (HA) EMBOLIZATION WITH DISTAL IMPLANT OF ENDOVASCULAR EXTENSIONS DUE TO ENDOLEAK IB. THESE DATA ARE SUMMARIZED IN TABLE 3. A TOTAL OF 69 PATIENTS WERE SUBMITTED TO EVAR ASSOCIATED WITH CONCOMITANT HA EMBOLIZATION WITH COILS (ZENITH GROUP 37.3% AND ENDURANT GROUP 49.4%, P=0.089). THERE WERE 19 PATIENTS SUBMITTED TO ZENITH BIFURCATED ILIAC SIDE ZBIS (COOK MEDICAL), WITH A HIGHER INCIDENCE IN ZENITH GROUP 26.9% ALTHOUGH ENDURANT GROUP HAD 1.1%, P<0.001. A TOTAL OF 21 PATIENTS WERE SUBMITTED TO BELL BOTTOM IMPLANTS IN COMMON ILIAC ARTERIES, WITH NO DIFFERENCES AMONG BOTH GROUPS (GROUP ZENITH 10.4% AND ENDURANT GROUP 15.7%, P=0.35). THOSE PATIENTS SUBMITTED TO ZBIS AND BELL BOTTOM WERE EVALUATED IN FOLLOW-UP, WITHOUT COMPLICATIONS AND ENDOLEAKS. REGARDING THE PATENCY OF THE HA, BEFORE SURGERY 95.5% OF THE PATIENTS HAD BILATERAL PATENCY OF HA, HOWEVER, AFTER SURGERY 96.8% OF THE PATIENTS HAD AT LEAST ONE HA PATENT. THE MEAN DIAMETERS OF THE AORTOILIAC ANEURYSMS WERE LENGTH OF AORTIC NECK 20.00 MM, (ZENITH GROUP 19.88 MM VS ENDURANT GROUP 18.34 MM, P=0.75), DIAMETER OF AORTIC ANEURYSM 71.66 +/- 22.6 MM (ZENITH GROUP 70.68 =/- 21.7 MM, ENDURANT GROUP 72.67 =/- 20.7 MM, P=0.92), RIGHT COMMON ILIAC ARTERY 14 =/- 10.1(ZENITH GROUP 13.68 =/-11.7 MM, ENDURANT GROUP 14.68 =/- 10.7 =/- 10.7 MM, P=0.93), LEFT COMMON ILIAC ARTERY 18.03 =/- 10.3 MM (ZENITH GROUP 18.58 =/- 10.2 MM, ENDURANT GROUP 17.68 =/-10.1 MM, P=0.91), RIGHT EXTERNAL ILIAC DIAMETER 13.40 =/-0.8 MM (ZENITH GROUP 13.68 =/-10.7 MM, ENDURANT GROUP 13.58 +/- 11. 7 MM, P=0.92), LEFT EXTERNAL ILIAC DIAMETER 10.81 +/- 0.6 MM (ZENITH GROUP 10.68 =/-2.7 MM, ENDURANT GROUP 10.67 =/- 1.7 MM, P=0.94) RIGHT INTERNAL ILIAC DIAMETER 15.77 =/-10.2 MM (ZENITH GROUP 13.68 =/-1.7 MM, ENDURANT GROUP 15.69 =/-1.8 MM, P=0.93), NECK DIAMETER 22.00 =/- 7.6 MM (ZENITH GROUP 21.16 =/- 6.8 MM, ENDURANT GROUP 22.10 =/-6.7 MM, P=0.48) AND LEFT INTERNAL ILIAC DIAMETER 16.50 =/-5.6 MM (ZENITH GROUP 17.68 =/- 5.7 MM, ENDURANT GROUP 16.68 =/- 16.7 MM, P=0.95). (TABLE 3). REGARDING THE DISTAL LANDING ZONE, THE ILIAC COMMON ARTERY WAS THE MOST COMMON WITH 243 LIMBS, WITHOUT STATISTICAL SIGNIFICANCE AMONG THE GROUPS. MOREOVER, THE ILIAC SEAL ZONE LENGTH WAS 34 MM, AND THE ILIAC SEAL ZONE DIAMETER WAS 16.63 MM, WITH NO DIFFERENCES AMONG THE GROUPS. THESE DATA ARE SUMMARIZED IN TABLE 4. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN PREOPERATIVE MTT AND THE INCIDENCE OF LATE ENDOLEAKS IN ALL LOCATIONS. TABLE 5 SUMMARIZES THE CORRELATION OF PREOPERATIVE THROMBUS LOAD ACCORDING TO ZONES AND THE INCIDENCE OF ENDOLEAKS. WE PERFORMED A UNIVARIATE AND MULTIVARIATE LINEAR REGRESSION ANALYSIS TO IDENTIFY FACTORS RELATED TO SURVIVAL RATE (TABLE 6). THE LINEAR REGRESSION ANALYSIS FOR SURVIVAL RATES SHOWED THAT CHRONIC KIDNEY DISEASE (P=0.03; HAZARD RATIO [HR]=2.82, CI=1.07¿4.44), WAS THE ONLY FACTOR RELATED TO POORER SURVIVAL RATES IN BOTH UNIVARIATE AND MULTIVARIATE ANALYSIS. A UNIVARIATE AND MULTIVARIATE LINEAR REGRESSION ANALYSIS WAS PERFORMED TO IDENTIFY FACTORS RELATED TO REINTERVENTION (TABLE 7). THE LINEAR REGRESSION ANALYSIS SHOWED THAT THE PRESENCE OF ENDOLEAKS (P<0.001, HR=6.69, CI=2.26¿8.48), TYPE OF ENDOGRAFT DEVICE (ZENITH GRAFT) (P=0.003, HR=2.213, CI=1.140¿3.943) AND LIMB GRAFT OCCLUSION (P<0.001, HR=8.02, CI=1.60¿9.99) WERE RELATED TO REINTERVENTION IN BOTH UNIVARIATE AND MULTIVARIATE ANALYSIS. THE OVERALL SURVIVAL IN A KAPLAN¿MEIER AT 720 DAYS WAS82.3% IN THE ZENITH GROUP AND 89.1% IN THE ENDURANT GROUP, WITH NO STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P=0.09) (FIGURE 1). REGARDING ANEURYSM-RELATED MORTALITY, THERE WERE 28 CASES (17.9%) IN TOTAL COHORT GLOBALLY, WITH HIGHER INCIDENCE AT ZENITH GROUP (17 CASES; 25,4%) THAN ENDURANT GROUP (11 CASES, 12.4%), P=0.03. THE FREEDOM FROM REINTERVENTION RATES IN A KAPLAN¿MEIER AT 720 DAYS WAS 82.8% IN THE ZENITH GROUP AND 93.2% IN THE ENDURANT GROUP, WITH STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P=0.001) (FIGURE 2). ALL ENDOLEAKS PREVALENCE IN A KAPLAN¿MEIER AT 720 DAYS WAS 34.3% IN THE ZENITH GROUP AND 14.6% IN THE ENDURANT GROUP, WITH STATISTICAL SIGNIFICANCE AMONG THE GROUPS (P<0.001) WITH HIGHER RATES IN THE ZENITH GROUP (FIGURE 3). REFERENCE DE ATHAYDE SOARES, R., PORTELA, M. V., AMARO, K., NASSER, A. I., PEDROSA, K. DE, & SACILOTTO, R. (2024). THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS. JOURNAL OF ENDOVASCULAR THERAPY. HTTPS://DOI.ORG/10.1177/15266028241270895 THE FOCUS OF THIS REPORT IS THE FOUR PATIENTS WITH TYPE IB ENDOLEAKS ON AN UNKNOWN ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AND REQUIRED ZENITH BRANCH ENDOVASCULAR GRAFT- ILIAC BIFURCATION PLACEMENTS AND/OR HYPOGASTRIC EMBOLIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961529 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention