ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2025-00589
- Event Type
- Injury
- Date Received
- May 23, 2025
- Report Date
- May 25, 2026
- 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
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.
CORRECTION: H6 - ANNEX A AND ANNEX G. INVESTIGATION ¿ EVALUATION: AS REPORTED IN THE LITERATURE ARTICLE ¿THE ENZEN TRIAL: ANALYSIS OF EVAR ENDOPROSTHESIS ZENITH AND ENDURANT FOR INFRARENAL AORTOILIAC ANEURYSMS REGARDING OUTCOMES, ENDOLEAKS, AND REINTERVENTIONS," DE ATHAYDE SOARES ET AL, 2024, TWO PATIENTS REQUIRED BOWEL RESECTION DUE TO BOWEL ISCHEMIA FOLLOWING PLACEMENT OF ZENITH FLEX (PREFIX TFFB) MAIN BODY GRAFTS (LOT, RPN UNKNOWN). THE PATIENT SELECTION CRITERIA FOR THE STUDY WERE AS FOLLOWS. 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. THE STUDY INCLUDED PATIENTS IMPLANTED WITH BOTH MEDTRONIC ENDURANT II AND COOK ZENITH FLEX GRAFTS. THE CHOICE OF THE SPECIFIC ENDOGRAFT WAS BASED IN ANATOMIC CRITERIA: NECK LENGTH >10 MM FOR ENDURANT II OR >15 MM FOR ZENITH FLEX. A TOTAL OF 156 PATIENTS UNDERWENT EVAR, OF WHICH 67 WERE IMPLANTED WITH ZENITH FLEX, AND ALL WERE REPORTED TO HAVE RESPECTED IFU INDICATIONS. FOR THE ZENITH COHORT, PRE-EXISTING CONDITIONS INCLUDED ARTERIAL HYPERTENSION (83.6%), TOBACCO USE (62.7%), DIABETES (25.4%), AND CARDIAC DISEASE (14.9%) (TABLE 2). 89.6% OF PATIENTS WHO WERE IMPLANTED WITH ZENITH HAD AORTOILIAC ANEURYSMS; 3.8% HAD COMMON ILIAC ANEURYSMS; 0.6% HAD INFRARENAL AORTIC ANEURYSMS. ALL PATIENTS WERE SCHEDULED FOR FOLLOW-UP AT 1, 6, AND 12 MONTHS AFTER DISCHARGE. THE MEAN CLINICAL FOLLOW-UP PERIOD WAS 760 +/- 80 DAYS. TWO PATIENTS REQUIRED BOWEL RESECTION DUE TO BOWEL ISCHEMIA FOLLOWING PLACEMENT OF ZENITH FLEX (PREFIX TFFB) MAIN BODY GRAFTS (LOT, RPN UNKNOWN). REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT APPROPRIATE INSPECTIONS ARE IN PLACE RELATIVE TO THE REPORTED DEVICE FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION PROVIDED. COOK WAS ALSO ABLE TO REVIEW PRODUCT LABELING. THIS DEVICE WAS PACKAGED WITH IFU T_ZAAAF_REV3, WHICH PROVIDES THE FOLLOWING RELATED TO THE REPORTED FAILURE MODE: 2. INDICATIONS FOR USE: THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE Z-TRAK INTRODUCTION SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS, NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: WITH A LENGTH OF AT LEAST 15MM, WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 32 MM AND NO LESS THAN 18 MM WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA. ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 6.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL). 4 WARNINGS AND PRECAUTIONS: 4.1 GENERAL: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS AND PRECAUTIONS MAY LEAD TO SERIOUS CONSEQUENCES OR INJURY TO THE PATIENT. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA. 5. ADVERSE EVENTS: 5.2 POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: BOWEL COMPLICATIONS (E.G. ILEUS, TRANSIENT ISCHEMIA, INFARCTION, NECROSIS). EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION. 8. PATIENT COUNSELING INFORMATION: IN ADDITION TO THE RISKS AND BENEFITS OF AN ENDOVASCULAR REPAIR, THE PHYSICIAN SHOULD ASSESS THE PATIENT¿S COMMITMENT AND COMPLIANCE TO POSTOPERATIVE FOLLOW-UP AS NECESSARY TO ENSURE CONTINUING SAFE AND EFFECTIVE RESULTS. LISTED BELOW ARE ADDITIONAL TOPICS TO DISCUSS WITH THE PATIENT AS TO EXPECTATIONS AFTER AN ENDOVASCULAR REPAIR: THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS 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 ENHANCED FOLLOW-UP. THERE IS NO EVIDENCE FROM THE INFORMATION PROVIDED THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE FROM THE INFORMATION PROVIDED OF NONCONFORMING PRODUCT IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THIS INVESTIGATION, A DEFINITIVE CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
COOK WAS INFORMED OF TWO PATIENTS WITH BOWEL ISCHEMIA FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING AN UNKNOWN ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. 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 TWO PATIENTS WITH BOWEL ISCHEMIA FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING AN UNKNOWN ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND REQUIRED BOWEL RESECTION.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549887 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |