BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22511624 · Received July 15, 2025

    Report

    Report Number
    1820334-2025-00849
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 12, 2026
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    00827002552388
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    INVESTIGATION ¿ EVALUATION COOK WAS NOTIFIED THAT THROMBUS FORMATION WAS IDENTIFIED IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG GRAFT PLACED ON THE LEFT. THE 66-YEAR-OLD MALE PATIENT HAD AN INITIAL FEVAR (FENESTRATED ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE COMPLETED ON (B)(6) 2024. DURING THE PROCEDURE, THE FOLLOWING COOK DEVICES WERE PLACED: WILLAM COOK AUSTRALIA (WCA), ZENITH FENESTRATED+ (ZFEN+) ENDOVASCULAR GRAFT, RPN: ZFEN+32-203-CI. WILLAM COOK AUSTRALIA (WCA), ZENITH UNIVERSAL DISTAL BODY 2.0, RPN: UNIBODY2-24-115-CL COOK INCORPORATED (CINC), ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-16-74-ZT PLACED ON THE LEFT. COOK INCORPORATED (CINC), ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-16-90-Z PLACED ON THE RIGHT. DURING THE PROCEDURE, A TYPE 1B ENDOLEAK WAS OBSERVED ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT) PLACED ON THE PATIENT¿S RIGHT AND ADDITIONAL BALLOONING WAS COMPLETED TO RESOLVE THE ENDOLEAK. ALSO, A WILLIAM COOK AUSTRALIA, COOK ZILVER 635 BILIARY SELF-EXPANDING STENT RPN: ZIB6-80-14.0-60 WAS PLACED IN THE RIGHT ILIAC LEG AND EXTENDED TO THE RIGHT EXTERNAL ILIAC ARTERY. ACCORDING TO THE CUSTOMER, THIS WAS A PLANNED ADDITIONAL PROCEDURE DUE TO A TORTUOUS RIGHT EXTERNAL ILIAC ARTERY WITH NARROWING. AT THE END OF THE PROCEDURE, A LIKELY TYPE IV ENDOLEAK WAS NOTED; HOWEVER, ON THE POSTOPERATIVE COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) COMPLETED ON DAY TWO, THE ENDOLEAK WAS NOT PRESENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED ON (B)(6) 2025, 200 DAYS POST PROCEDURE. THE CUSTOMER REVIEWED THE CT SCAN AND INDICATED THAT NO ENDOLEAK WAS PRESENT. NO SEPARATION OF COMPONENTS OCCURRED. THERE WAS NO EVIDENCE OF MIGRATION OF COMPONENTS MORE THAN OR EQUAL TO 10 MM OR DEVICE INTEGRITY ISSUES. THERE WAS NO EVIDENCE OF THROMBUS. AN INDEPENDENT LABORATORY REVIEWED THE CT SCAN THAT WAS COMPLETED ON (B)(6) 2025. THE INDEPENDENT LABORATORY AGREED WITH THE CUSTOMER REVIEW OF THE IMAGING; NO SEPARATION OF COMPONENTS OCCURRED, NO EVIDENCE OF MIGRATION OF COMPONENTS MORE THAN OR EQUAL TO 10 MM, AND NO EVIDENCE OF DEVICE INTEGRITY ISSUES. HOWEVER, THE INDEPENDENT LABORATORY MADE AN INITIAL FINDING OF THROMBUS WITHIN THE ZFEN+ DEVICE, UNIBODY 2 DEVICE, RIGHT ILIAC LEG GRAFT AND LEFT ILIAC LEG GRAFT. THIS REPORT FOCUSES ON THE THROMBUS FORMATION IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT) PLACED ON THE PATIENT¿S LEFT THAT WAS IDENTIFIED IN IMAGING COMPLETED ON (B)(6) 2025, 200 DAYS POST PROCEDURE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, IMAGING WAS PROVIDED FOR THE INVESTIGATION. THE IMAGE REVIEWER NOTED ¿1. A DELAYED ENDOLEAK ADJACENT TO THE ZSLE-16-90-ZT ON RETROGRADE RIGHT EIA ANGIOGRAPHY WAS ACCOMPANIED BY A SECOND ENDOLEAK ALONG THE RIGHT LATERAL SEAL ZONE. (FIGURE 1) ANGIOGRAPHICALLY, THE ENDOLEAKS WERE MOST SUSPICIOUS FOR TINY TYPE IB ENDOLEAKS PROVOKED BY THE RETROGRADE INJECTION. HOWEVER, ON FOLLOW UP CTA, ONLY THE ENDOLEAK ADJACENT THE ZSLE-16-90-ZT PERSISTED. (FIGURE 2) THIS CONFIRMED THAT THE ENDOLEAKS AT ANGIOGRAPHY WERE UNRELATED. THE RIGHT LATERAL ENDOLEAK WAS A PROVOKED TYPE IB ENDOLEAK WHILE THE ZSLE-16-90-ZT ENDOLEAK WAS LIKELY AN ENDOLEAK THROUGH A VERY SMALL FABRIC HOLE (TYPE III B ENDOLEAK) SUCH AS A SUTURE HOLE. ALTHOUGH THE SITE LIKELY CLASSIFIED THE ENDOLEAK AS A TYPE IV ENDOLEAK TO DESCRIBE A TRANS-FABRIC LEAK, THERE WAS NO EVIDENCE OF DIFFUSE FABRIC POROSITY MEETING THE DEFINITION OF A TYPE IV ENDOLEAK. 2. THE ENDOLEAK WAS ASSOCIATED WITH TYPE II ENDOLEAKS INVOLVING THE IMA AND ADJACENT LUMBAR ARTERIES. (FIGURE 3) THE FLOW DIRECTION OF THE ARTERIES CANNOT BE DETERMINED ON THE CTA. GIVEN THE ARTERY SIZES, THE LUMBAR FLOW WOULD MOST LIKELY BE AWAY FROM THE SAC AND THE IMA INDETERMINATE. 3. THE ZSLE-16-90-ZT WAS TREATED WITH MOLDING BALLOON ANGIOPLASTY IN AND JUST INFERIOR THE GATE/LEG OVERLAP. NO OVEREXPANSION WAS OBSERVED DURING THE INFLATION OR ON FOLLOW UP CTA. (FIGURE 4) 4. THE ZSLE WAS NOT KINKED. JUST INFERIOR THE ZSLE, THE ZSLE/RIGHT EIA JUNCTION WAS ACUTELY ANGLED AND MODERATELY NARROWED. (FIGURE 1) THIS ACUTENESS WAS SMOOTHED, AND THE STENOSIS RESOLVED WITH THE ADDITION OF A ZILVER STENT. (FIGURE 5) 5. SMOOTH MURAL THROMBUS LINED THE MAINBODY AND THE ZSLES AT SIX MONTHS. (FIGURE 6) THE MURAL THROMBUS THICKNESS WAS MILD AND WITHIN NORMAL VARIATION. 6. THE ENDOLEAK PRESENT POST PROCEDURE RESOLVED BY SIX MONTHS. THE ANEURYSM DIAMETER WAS STABLE AT SIX MONTHS. (FIGURE 7) IMPRESSION: 1. THE COMPLAINT OF KINKING IS NOT CONFIRMED. 2. THE COMPLAINT OF ENDOLEAK IS CONFIRMED HOWEVER THE ENDOLEAK TYPE IS NOT CONFIRMED. THE ENDOLEAK MOST LIKELY WAS A TYPE IIIB ENDOLEAK WITH TYPE II ANEURYSM SAC EGRESS. 3. MURAL THROMBUS WITHIN THE MAINBODY AND THE ZSLE¿S IS CONFIRMED. THE MURAL THROMBUS THICKNESS WAS MILD AND WITHIN NORMAL VARIATION. 4. THE ENDOLEAK PRESENT POST IMPLANT HAD RESOLVED BY SIX MONTHS.¿ ADDITIONALLY, 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 FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER EVENTS REPORTED FOR THE RELATED FAILURE MODE. COOK WAS ABLE TO REVIEW PRODUCT LABELING. THE PRODUCT IFU, T_ZAAASZ_REV4 ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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. ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SIRE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. 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 LEG GRAFT. 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. 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. 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., ENDOLEAKS, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. 4.5 IMPLANT PROCEDURE: INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z ENDOVASCULAR AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. EXCESSIVE OVERLAP 10MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. 5.2 POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: AORTIC DAMAGE, INCLUDING PERFORATION, DISSECTION, BLEEDING, RUPTURE AND DEATH ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT/ SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATION; EROSION; PUNCTURE; PERGRAFT FLOW; AND CORROSION. GRAFT OR NATIVE VESSEL OCCLUSION VESSEL DAMAGE. 7.1 INDIVIDUALIZATION OF TREATMENT THE RISKS AND BENEFITS SHOULD BE CAREFULLY CONSIDERED FOR EACH PATIENT BEFORE USE OF THE ZENITH SPIRAL-Z AAA ILIAC LEG. 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 ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR THE RISK OF ANEURYSM RUPTURE COMPARED TO THE RISK OF TREATMENT WITH ZENITH SPIRAL-Z AAA .ILIAC LEG 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 ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT. THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 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: 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. 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 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. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND MANUFACTURING DOCUMENTS SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, AN EXPERT REVIEW OF IMAGING PROVIDED BY THE FACILITY, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THROMBUS FORMATION COULD NOT BE DETERMINED. ALTHOUGH A DEFINITIVE CAUSE FOR THE THROMBUS FORMATION COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITIONS, AND ANATOMY WERE CONTRIBUTING FACTORS. 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.

    Description of Event or Problem · 0

    COOK WAS NOTIFIED THAT AN INDEPENDENT LABORATORY REVIEWING IMAGING FOR A STUDY INDICATED THAT THROMBUS FORMATION HAD OCCURRED IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG PLACED ON THE PATIENT¿S LEFT. PRE STUDY PROCEDURE IMAGING (COMPUTED TOMOGRAPHY SCAN) WAS COMPLETED ON (B)(6) 2024 (58 DAYS PRIOR TO THE PROCEDURE). IMAGING WAS REVIEWED TO SCREEN FOR INCLUSION INTO THE STUDY. THE MOST PROXIMAL EXTENT OF THE ANEURYSM WAS BETWEEN THE RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY (SMA). THE PROXIMAL SEAL ZONE WAS APPROPRIATE LENGTH AND DIAMETER. IT WAS FREE FROM PROHIBITIVE OCCLUSIVE DISEASE, CALCIFICATION, AND THROMBUS. THE DISTAL SEAL ZONE WAS THE APPROPRIATE LENGTH AND DIAMETER. THE DISTAL SEAL ZONE LOCATION WAS THE ILIAC ARTERIES. THE TARGETED VISCERAL VESSELS WERE APPROPRIATE LENGTH AND DIAMETER FOR BRIDGING STENT PLACEMENT. THE ARTERIAL TORTUOSITY, CALCIFICATION, AND DIAMETER WAS CONDUCIVE TO THE PLACEMENT OF AN ENDOVASCULAR DELIVERY SYSTEM. MEDICAL AND ANATOMICAL CRITERIA - AORTA THERE WERE NO ENDOVASCULAR STENTS IN THE ABDOMINAL OR THORACIC AORTA. THERE WEREN'T ANY PREVIOUS STENTS IN ANY VESSEL THAT WOULD BE ACCOMMODATED WITH A FENESTRATION OR BRIDGING STENT. THE MOST PROXIMAL EXTENT OF ANEURYSM WAS WITHIN 20 MM PROXIMAL TO THE CELIAC AND 15 MM DISTAL TO THE LOWEST RENAL ARTERY. THE ANEURYSM WAS AN EXTENT IV. THE PROXIMAL SEAL ZONE WAS FREE FROM PROHIBITIVE OCCLUSIVE DISEASE, CALCIFICATION, AND THROMBUS. THE ARTERIAL TORTUOSITY, CALCIFICATION, AND ARTERIAL DIAMETER WERE CONDUCIVE TO THE PLACEMENT OF ENDOVASCULAR DELIVERY SYSTEM. THE MAXIMUM ANGULATION ABOVE THE INFRA-RENAL AORTA WAS 26 DEGREES. THE ANGULATION BETWEEN INFRA-RENAL AORTA AND ANEURYSM CENTER LINE WAS 56 DEGREES. THE LENGTH OF THE PROXIMAL SEAL ZONE WAS 60 MM. THE LENGTH FROM LOWEST TARGETED VESSEL (MOST INFERIOR ASPECT) TO THE AORTIC BIFURCATION WAS 161 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 29 MM. THE DIAMETER OF AORTA AT THE LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 26.2 MM. THE % CHANGE IN SEAL ZONE DIAMETER THROUGHOUT THE LENGTH OF THE SEAL ZONE WAS 9.66 THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 69 MM. ANATOMICAL CRITERIA ¿ VISCERAL THE PERCENTAGE OF STENOSIS WAS LESS THAN 50% FOR THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES. THE LENGTH FROM THE CELIAC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 17 MM. THE DIAMETER OF THE CELIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 6.5 MM. THE LENGTH FROM THE SUPERIOR MESENTERIC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 45 MM. THE DIAMETER OF THE SUPERIOR MESENTERIC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 6.3 MM. THE LENGTH FROM THE RIGHT RENAL OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 34 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 5.7 MM. THE LENGTH FROM THE LEFT RENAL OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 32 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 4.9 MM. THE LENGTH FROM THE OSTIUM OF THE RIGHT ILIAC ARTERY TO THE FIRST MAJOR BIFURCATION WAS 59 MM. THE DIAMETER OF THE RIGHT ILIAC ARTERY AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 13 MM. NO STENOSIS WAS PRESENT IN THE RIGHT ILIAC ARTERY. THE LENGTH FROM THE OSTIUM OF THE LEFT ILIAC ARTERY TO THE FIRST MAJOR BIFURCATION WAS 58 MM. THE DIAMETER OF THE LEFT ILIAC ARTERY AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 14 MM. NO STENOSIS WAS PRESENT IN THE LEFT ILIAC ARTERY. THE ILIAC ARTERIES ACCESS VESSELS HAD A MINIMUM INNER DIAMETER FROM INTRODUCTION SITE TO THE AORTA TO ACCOMMODATE THE DELIVERY SYSTEM OF THE DEVICES. ALSO NOTABLE. THERE WAS FOCAL STENOSIS IN THE RIGHT EXTERNAL ILIAC ARTERY. THERE WERE TWO SMALL EARLY BRANCHES FROM THE CELIAC TRUNK. THE PROXIMAL CELIAC TRUNK WAS FUNNEL SHAPED. THE SMA IS DISEASED JUST BEYOND THE SEAL ZONE. THE PROXIMAL SMA IS FUNNEL SHAPED. THE RIGHT RENAL PROXIMAL ARTERY IS FUNNEL SHAPED. THE LEFT RENAL PROXIMAL ARTERY IS FUNNEL SHAPED. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN WAS COMPLETED ON (B)(6) 2024. COOK PLANNING AND SIZING REVIEWED THE IMAGING. THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR CALCIFICATION. PARTIAL THROMBUS WAS PRESENT IN THE PROXIMAL SEALING ZONE. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE RIGHT COMMON ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MODERATE. THE LEFT COMMON ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MODERATE. NO OCCLUSIVE DISEASE WAS PRESENT IN THE COMMON ILIAC ARTERIES. THE RIGHT EXTERNAL ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE LEFT COMMON ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE RIGHT EXTERNAL ILIAC ARTERY WAS FREE OF OCCLUSIVE DISEASE. THE LEFT EXTERNAL ILIAC ARTERY WAS FREE OF OCCLUSIVE DISEASE. THE LEFT AND RIGHT FEMORAL ARTERIES DID NOT HAVE CALCIFICATION AND WERE FREE OF OCCLUSIVE DISEASE. THE RIGHT ILIAC ARTERY TORTUOSITY WAS DESCRIBED AS MODERATE. THE LEFT ILIAC ARTERY TORTUOSITY WAS DESCRIBED AS MILD. ANATOMICAL MEASUREMENTS: THE AORTA DIAMETER AT THE LOCATION OF MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 67 MM. THE LENGTH OF THE SUITABLE PROXIMAL SEAL ZONE WAS 40 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 28.2 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 27 MM. THE PERCENTAGE CHANGE IN SEAL ZONE DIAMETER THROUGHOUT LENGTH OF SEAL ZONE WAS 4.26%. THE LENGTH FROM LOWEST TARGETED VESSEL (MOST INFERIOR ASPECT) TO THE AORTIC BIFURCATION WAS 160 MM. ANGULATION BETWEEN INFRA-RENAL AORTA AND ANEURYSM CENTER LINE WAS 5 DEGREES. THE MAXIMUM ANGULATION ABOVE THE INFRA-RENAL AORTA (WITHIN REGION OF ZFEN+ AND DELIVERY SYSTEM WAS 10 DEGREES. THE PERCENTAGE OF STENOSIS WAS LESS THAN 50% FOR THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES. THE LENGTH FROM THE CELIAC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 30 MM. THE DIAMETER OF THE CELIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 6.2 MM. THE LENGTH FROM THE SUPERIOR MESENTERIC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 45 MM. THE DIAMETER OF THE SUPERIOR MESENTERIC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 6.2 MM. THE LENGTH FROM THE RIGHT RENAL ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 40 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 4.8 MM. THE LENGTH FROM THE LEFT RENAL OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 30 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 5.1 MM. THE DIAMETER OF THE RIGHT ILIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 12 MM. THE LENGTH FROM THE RIGHT ILIAC OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 50 MM. THE RIGHT ILIAC ARTERY HAD 5% STENOSIS. THE DIAMETER OF THE LEFT ILIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER-WALL) WAS 13 MM. THE LENGTH FROM THE LEFT ILIAC OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 50 MM. THE LEFT ILIAC ARTERY HAD 5% STENOSIS. THE LOCATION OF THE INTENDED DISTAL LANDING ZONES MAINTAINED THE PATENCY OF THE INTERNAL ILIAC ARTERY. AN INDEPENDENT LAB REVIEWED THE COMPUTED TOMOGRAPHY SCAN THAT WAS COMPLETED ON (B)(6) 2025. THE DIAMETER, LENGTH, CALCIFICATION, AND PERCENTAGE OF STENOSIS FOR THOSE VESSELS INCORPORATED INTO THE CUSTOM-MADE DEVICE PROCEDURE WERE PROVIDED. THE PROXIMAL SEAL ZONE DID NOT HAVE THROMBUS PRESENT, WAS NOT CALCIFIED, AND DID NOT HAVE OCCLUSIVE DISEASE. NO STENOSIS WAS NOTED IN THE COMMON ILIAC ARTERIES IN THE REVIEW. THE PROXIMAL SEAL ZONE SHAPE WAS PARALLEL. MILD CALCIFICATION WAS PRESENT IN THE RIGHT COMMON ILIAC ARTERY, BUT NO OCCLUSIVE DISEASE. OCCLUSIVE DISEASE WAS PRESENT IN THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT FEMORAL ARTERY. MILD CALCIFICATION WAS PRESENT IN THE LEFT COMMON ILIAC ARTERY. THE RIGHT ILIAC TORTUOSITY WAS DESCRIBED AS MODERATE, AND 5% STENOSIS WAS PRESENT. MILD CALCIFICATION WAS PRESENT IN THE LEFT COMMON ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY. OCCLUSIVE DISEASE WAS PRESENT IN THE EXTERNAL ILIAC ARTERY. THE TORTUOSITY OF THE LEFT AND RIGHT ILIAC ARTERIES WAS DESCRIBED AS MILD. A PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, ONE DAY PRIOR TO THE PROCEDURE. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. A PHYSICIAN PROCTOR WAS NOT PRESENT FOR THE INDEX PROCEDURE. IPSILATERAL ACCESS WAS OBTAINED PERCUTANEOUSLY IN THE LEFT FEMORAL ARTERY. CONTRALATERAL ACCESS WAS OBTAINED PERCUTANEOUSLY IN THE RIGHT FEMORAL ARTERY. PER PATIENT VASCULAR OPERATIVE REPORT: ANESTHESIA: GENERAL BLOOD LOSS: 20 ML COMPLICATIONS: NONE SPECIMENS: NONE RADIATION TIME(MIN}: 49.7. RADIATION EXPOSURE (MGY}: 4763 TOTAL PROCEDURE TIME (MIN}: 135 CONTRAST VOLUME (ML}: 110. INDICATIONS: PATIENT IS A 66-YEAR-OLD MALE WITH HISTORY OF AN ASYMPTOMATIC 6.8 CM PARARENAL ABDOMINAL AORTIC ANEURYSM, WELL ABOVE THE ACCEPTED TREATMENT THRESHOLD, INITIALLY DISCOVERED DURING A HOSPITAL PRESENTATION FOR ACUTE CORONARY SYNDROME. FOLLOWING SUCCESSFUL TREATMENT OF HIS CORONARY DISEASE, THE PATIENT WAS OFFERED THE PROCEDURE BELOW. THE RISKS, BENEFITS, ALTERNATIVES, DESCRIPTION OF PROCEDURE WERE DISCUSSED. THE PATIENT UNDERSTOOD THESE RISKS AND ELECTED TO PROCEED. PROCEDURE(S}: 1. PERCUTANEOUS ACCESS AND CLOSURE OF BILATERAL COMMON FEMORAL ARTERIES WITH THE MANTA DEVICE VIA ULTRASOUND GUIDED ACCESS FOR DELIVERY OF ENDOPROSTHESIS (16 FR RIGHT, 18 FR LEFT) 2. AORTOGRAM AND BRANCHES WITH RADIOGRAPHIC SUPERVISION AND INTERPRETATION 3. FIRST ORDER SELECTIVE CATHETERIZATION OF CELIAC, SUPERIOR MESENTERIC AND BILATERAL RENAL ARTERIES FROM BILATERAL FEMORAL APPROACH 4. ENDOVASCULAR REPAIR OF PARARENAL AORTIC ANEURYSM WITH FENESTRATED DEVICE (ZFEN+32-203-CL) WITH FOUR VISCERAL BRANCHES AND UNIBODY BI-ILIAC ABDOMINAL AORTIC COMPONENT (ZFEN UNIVERSAL DISTAL BODY 2.0 UNIBODY2-24-115-CL). 1. CELIAC: 7 MM X 27 MM BRIDGING STENT. 2. SUPERIOR MESENTERIC: 7 MM X 37 MM BRIDGING STENT 3. RIGHT RENAL: 6 MM X 28 MM BRIDGING STENT. 4. LEFT RENAL: 6 MM X 28 MM BRIDGING STENT. 7. RADIOGRAPHIC SUPERVISION AND INTERPRETATION OF FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. 5. DISTAL EXTENSION OF BILATERAL ILIAC EXTENSION LIMBS (RIGHT 16 MM X 90 MM SPIRAL-Z (RE-ENFORCED WITH 14 M X 60 MM ZILVER AND EXTENDED TO RIGHT EXTERNAL ILIAC ARTERY) AND LEFT 16 MM X 74 MM SPIRAL-Z). 6. RADIOGRAPHIC SUPERVISION AND INTERPRETATION OF BILATERAL ILIAC EXTENSION LIMBS. FINDINGS: 1. SUCCESSFUL EXCLUSION OF PARARENAL ANEURYSM WITH AORTIC ENDOGRAFT WITH EVIDENCE OF TYPE IV ENDOLEAK ON COMPLETION. 2. EXCELLENT FILLING OF CELIAC, SUPERIOR MESENTERIC AND BILATERAL RENAL ARTERY STENTS. 3. PALPABLE PEDAL PULSES BILATERALLY AT THE CONCLUSION OF THE CASE. DESCRIPTION OF PROCEDURE: PATIENT WAS TAKEN TO THE OPERATING ROOM, PLACED SUPINE ON THE OPERATING TABLE AND PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A TIMEOUT WAS PERFORMED. APPROPRIATE IV ANTIBIOTICS WERE GIVEN. THE BILATERAL COMMON FEMORAL ARTERIES WERE ACCESSED WITH MICROPUNCTURE NEEDLES WITH ULTRASOUND GUIDANCE. CORRECT PLACEMENT WAS VERIFIED RADIOGRAPHICALLY. HEPARIN WAS GIVEN AND AN ACT WAS MAINTAINED ABOVE 250 FOR THE DURATION OF THE CASE. THE LEFT GROIN MICROSHEATH WAS UPSIZED TO A 7-FR SHEATH. NEXT, THE VASCULAR CLOSURE DEVICE WAS USED TO DETERMINE THE CORRECT ACCESS SITE DEPTH, AND ADDING ONE CM FOR THE CORRECT FUTURE DEPLOYMENT DEPTH. A 9-FR SHEATH WAS THEN INSERTED INTO THE RIGHT GROIN TO PLUG THE ARTERIOTOMY. THE PROCESS WAS THEN COMPLETED ON THE LEFT SIDE. A VERTEBRAL CATHETER WAS ADVANCED THROUGH THE RIGHT GROIN SHEATH INTO THE THORACIC AORTA, AND THE WIRE WAS EXCHANGED FOR A LUNDERQUIST WIRE. THE ACCESS WAS SERIALLY DILATED, AND A 16 FR SHEATH WAS INSERTED. A CATHETER WAS ADVANCED THROUGH THE LEFT SHEATH. THE ACCESS WAS SERIALLY DILATED AND AN 18 FR SHEATH WAS PLACED. A ZFEN+32-203-CL WAS ADVANCED INTO THE ABDOMINAL AORTA AFTER REMOVAL OF THE LEFT GROIN SHEATH. AN ANGIOGRAM WAS PERFORMED, AND A 3-D MAP WAS OVERLAYED. CORRECT POSITION WAS DETERMINED BY RADIOGRAPHIC MARKERS AND DEVICE FENESTRATIONS. THE DEVICE WAS PLACED IN THE APPROPRIATE POSITION IN THE SUPRACELIAC AORTA WITH FENESTRATIONS AT THE LEVEL OF THEIR RELATIVE VISCERAL VESSEL. THE DEVICE WAS PARTIALLY DEPLOYED DOWN TO THE DISTAL END WITH THE ASSISTANCE OF 3-D MAPPING. FROM THE CONTRALATERAL ACCESS, A CATHETER AND GUIDEWIRE WERE UTILIZED TO CANNULATE THE BOTTOM OF THE PARTIALLY DEPLOYED FENESTRATED COMPONENT. THE LUNDERQUIST WIRE WAS ADVANCED INTO THE BOTTOM OF THE ZFEN AND THE 16 FR SHEATH WAS ADVANCED THROUGH THE FENESTRATED COMPONENT. A STEERABLE SHEATH, VERTEBRAL CATHETER AND GUIDEWIRE WERE UTILIZED TO CANNULATE THE RIGHT RENAL ARTERY. ANGIOGRAM CONFIRMED INTRALUMINAL PLACEMENT. THE GUIDEWIRE WAS EXCHANGED FOR A ROSEN WIRE, WHICH WAS LEFT IN PLACE. THIS PROCESS WAS REPEATED FOR THE LEFT RENAL, SUPERIOR MESENTERIC AND CELIAC ARTERIES. NEXT, A 7 MM X 27 MM BRIDGING STENT WAS ADVANCED INTO THE CELIAC ARTERY AND LEFT IN PLACE, UNDEPLOYED. THE FENESTRATED GRAFT WAS THEN FULLY DEPLOYED, AND THE PROXIMAL SEAL WAS BALLOONED. THE VISCERAL BRANCHES WERE PERFORMED NEXT. A LATERAL PROJECTION WAS USED TO DEPLOY CELIAC AND MESENTERIC ARTERY STENTS TO ENSURE APPROPRIATE AORTIC OVERHANG. THE PREVIOUSLY UNDEPLOYED BRIDGING STENT WAS THEN INFLATED TO PROFILE AND FLARED WITH 10 MM X 20 MM BALLOON. REPEAT ANGIOGRAM SHOWED EXCELLENT FLOW THROUGH THE STENT. A 7 MM X 37 MM BRIDGING STENT WAS THEN ADVANCED AND DEPLOYED IN THE SUPERIOR MESENTERIC ARTERY AND FLARED WITH A 10 MM X 20 MM BALLOON. REPEAT ANGIOGRAM SHOWED EXCELLENT FLOW THROUGH THE STENT WITH NO TYPE IC OR ILL ENDOLEAK. THE RENAL BRANCHES WERE PERFORMED LAST. A 6 MM X 26 MM BRIDGING STENT WAS ADVANCED INTO THE RIGHT RENAL ARTERY, INFLATED TO PROFILE AND FLARED WITH AN 8 MM X 20 MM BALLOON. REPEAT ANGIOGRAM SHOWED EXCELLENT FLOW THROUGH THE STENT WITH NO TYPE IC OR ILL ENDOLEAK. LASTLY, A 6 MM X 26 MM BRIDGING STENT WAS ADVANCED INTO THE LEFT RENAL ARTERY, DEPLOYED AND FLARED WITH AN 8 MM X 20 MM BALLOON. REPEAT ANGIOGRAM SHOWED EXCELLENT FLOW THROUGH THE STENT WITH NO TYPE IC OR ILL ENDOLEAK. AN ANGIOGRAM WAS THEN PERFORMED TO VISUALIZE THE AORTIC BIFURCATION. A ZFEN UNIVERSAL DISTAL BODY 2.0 UNIBODY2-24-115-CL WAS ADVANCED INTO THE POSITION AND PARTIALLY DEPLOYED TO THE CONTRALATERAL GATE. THE CONTRALATERAL GATE WAS CANNULATED WITH A GUIDEWIRE AND A FLUSH CATHETER. LNTRA-ENDOGRAFT POSITION WAS CONFIRMED WITH A MOLDING AND OCCLUSION BALLOON. THE LUNDERQUIST WIRE WAS ADVANCED INTO THE THORACIC AORTA. THE MAIN BODY WAS THEN DEPLOYED IN ITS ENTIRETY. A 16 MM X 90 MM SPIRAL-Z EXTENSION LIMB WAS DEPLOYED INTO THE RIGHT COMMON ILIAC ARTERY. AN ANGIOGRAM WAS PERFORMED TO MARK THE LEFT ILIAC BIFURCATION. A 16 MM X 74 MM SPIRAL-Z CONTRALATERAL EXTENSION LIMB WAS DEPLOYED, LANDING CAUDAL TO THE BIFURCATION. A MOLDING AND OCCLUSION BALLOON WAS USED TO BALLOON THE PROXIMAL AND DISTAL SEAL AND STENT OVERLAP ZONES. ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF THE PARARENAL ANEURYSM WITH EXCELLENT FILLING OF ALL 4 VISCERAL BRANCHES, A LIKELY TYPE IV ENDOLEAK AND KINKING OF THE RIGHT ILIAC EXTENSION LIMB DISTALLY, AND THE DECISION WAS MADE TO EXTEND THE LIMB INTO THE EXTERNAL ILIAC ARTERY AND REINFORCE IT WITH A SELF-EXPANDING STENT. A 14 MM X 60 MM ZILVER WAS USED TO EXTEND THE LIMB AND POST-DILATED WITH AN 8 MM X 60 MM BALLOON. CATHETERS AND SHEATHS WERE REMOVED. VASCULAR CLOSURE DEVICES WERE USED TO CLOSE THE BILATERAL FEMORAL ARTERIAL PUNCTURES WITH SUCCESSFUL DEPLOYMENT. PROTAMINE WAS ADMINISTERED. HEMOSTASIS WAS OBTAINED AND STERILE DRESSINGS WERE APPLIED. THE PATIENT HAD PALPABLE PEDAL PULSES UPON COMPLETION AND TOLERATED THE PROCEDURE WELL AND WAS NEUROLOGICALLY INTACT AT END OF CASE. THE PATIENT WAS TRANSPORTED TO PACU IN STABLE CONDITION. THE PATIENT HAD THE FOLLOWING DEVICES PLACED DURING THE PROCEDURE: WILLIAM COOK AUSTRALIA, COOK ZENITH FENESTRATED PLUS MAIN BODY (RPN: ZFEN+32-203-CI) THERE WAS NO DIFFICULTY FLUSHING THE INTRODUCER SYSTEM AND REMOVING THE RELEASE WIRES. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE DEVICE FROM THE START TO THE END OF THE IMPLANT. THERE WAS NO DIFFICULTY CANNULATING THE FENESTRATIONS OR RETRACTING THE SHEATH. WILLIAM COOK AUSTRALIA, UNIVERSAL DISTAL BODY (RPN: UNIBODY2-24-81-CI): IPSILATERAL ACCESS WAS USED. THERE WERE FOUR COMPONENTS OF OVERLAPPING WITH THE PRECEDING STENT. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE DEVICE FROM THE START TO THE END OF THE IMPLANT. THERE WAS NO DIFFICULTY RETRACTING THE SHEATH OR REMOVING THE RELEASE WIRES. COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT): CONTRALATERAL ACCESS WAS USED TO PLACE THE DEVICE IN THE RIGHT COMMON ILIAC ARTERY. THERE WAS ONE STENT OVERLAP WITH THE PRECEDING DEVICE. COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT): IPSILATERAL ACCESS WAS USED TO PLACE THE DEVICE IN THE LEFT COMMON ILIAC ARTERY. THERE WERE TWO AND A HALF STENTS OVERLAPPING WITH THE PRECEDING DEVICE. WILLIAM COOK EUROPE, ZILVER 635 BILIARY SELF-EXPANDING STENT (RPN: ZIB6-80-14.0-60). THE DEVICE WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE ARTERY WAS TORTUOUS AND NARROW AND WAS REPORTED TO NEED A BARE STENT. IT WAS PLANNED TO PLACE THE STENT WAS PLACED AFTER THE STUDY DEVICES WERE IMPLANTED. COMPETITOR¿S BRIDGING STENT (7 MM X 27 MM): INTRODUCED CONTRALATERALLY, PLACED IN THE CELIAC ARTERY. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. THE INFLATION PRESSURE USED TO EXPAND THE BRIDGING STENT WAS EIGHT ATMOSPHERES. THE STENT WAS FLARED. A COMPETITOR¿S BALLOON WAS USED DURING FLARING. THE INFLATION PRESSURE OF THE FLARING BALLOON WAS SIX ATMOSPHERES. NO ISSUES WERE ENCOUNTERED DURING FLARING. COMPETITOR¿S BRIDGING STENT (7 MM X 37 MM): INTRODUCED CONTRALATERALLY, PLACED IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. THE INFLATION PRESSURE USED TO EXPAND THE BRIDGING STENT WAS EIGHT ATMOSPHERES. THE STENT WAS FLARED. A COOK ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, (RPN: PTA5-35-135-10-2.0) WAS USED DURING FLARING. THE INFLATION PRESSURE OF THE FLARING BALLOON WAS EIGHT ATMOSPHERES. NO ISSUES WERE ENCOUNTERED DURING FLARING. COMPETITOR¿S BRIDGING STENT (6 MM X 26 MM): INTRODUCED CONTRALATERALLY, PLACED IN THE RIGHT RENAL ARTERY. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. THE INFLATION PRESSURE USED TO EXPAND THE BRIDGING STENT WAS EIGHT ATMOSPHERES. THE STENT WAS FLARED. A COMPETITOR¿S BALLOON WAS USED DURING FLARING. THE INFLATION PRESSURE OF THE FLARING BALLOON WAS SIX ATMOSPHERES. NO ISSUES WERE ENCOUNTERED DURING FLARING. COMPETITOR¿S BRIDGING STENT (6 MM X 26 MM): INTRODUCED CONTRALATERALLY, PLACED IN THE LEFT RENAL ARTERY. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. THE INFLATION PRESSURE USED TO EXPAND THE BRIDGING STENT WAS EIGHT ATMOSPHERES. THE STENT WAS FLARED. A COMPETITOR¿S BALLOON WAS USED DURING FLARING. THE INFLATION PRESSURE OF THE FLARING BALLOON WAS SIX ATMOSPHERES. NO ISSUES WERE ENCOUNTERED DURING FLARING. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAPHY SCAN AND A CONE BEAM COMPUTED TOMOGRAPHY SCAN WAS COMPLETED ON (B)(6)2024. ALL DEVICES WERE PATENT AT THE CONCLUSION OF THE PROCEDURE AND THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. A TYPE IV ENDOLEAK THROUGH THE GRAFT BODY WAS PRESENT. AN INDEPENDENT LABORATORY REVIEWED THE IMAGING COMPLETED ON (B)(6) 2024 AND IDENTIFIED A TYPE 2 ENDOLEAK. ALL ACCESS AND DELIVERY OF ALL DEVICES WAS CONSIDERED SUCCESSFUL. SUCCESSFUL DEPLOYMENT IN THE INTENDED LOCATION FOR ALL DEVICES WAS ACHIEVED. ALL DEVICE DELIVERY SYSTEMS WERE WITHDRAWN SUCCESSFULLY. THERE WERE NO UNANTICIPATED CORRECTIVE INTERVENTION'S REQUIRED DURING THE PROCEDURE. THE PATIENT WAS NOT ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT BEGAN RESUMING ORAL FLUIDS ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024, TWO DAYS AFTER THE PROCEDURE. A FOLLOW UP CT SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2024, TWO DAYS POST PROCEDURE. THE DIAMETER, LENGTH, CALCIFICATION, AND PERCENTAGE OF STENOSIS FOR THOSE VESSELS INCORPORATED INTO THE CUSTOM-MADE DEVICE PROCEDURE WERE PROVIDED. ADDITIONALLY, AORTIC DIAMETERS AND ANEURYSM DIAMETERS WERE PROVIDED. THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES WERE ALL PATENT WITHIN THE STENT AND WITHIN THE VESSEL. THE ENDOGRAFT DEVICES WERE PATENT. NO STENOSIS GREATER THAN 50% WAS IDENTIFIED IN ANY TREATED VESSEL. THE DIAMETER AT THE LOCATION OF MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 68 MM. THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 14 MM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 13 MM. A TYPE 2 ENDOLEAK WAS PRESENT. NO SEPARATION OF COMPONENTS OCCURRED. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THERE WAS NO EVIDENCE OF THROMBUS WITHIN A STUDY DEVICE. AN INDEPENDENT LABORATORY REVIEWED THE CT SCAN THAT WAS COMPLETED ON (B)(6) 2024, TWO DAYS POST PROCEDURE. THE DIAMETER, LENGTH, CALCIFICATION, AND PERCENTAGE OF STENOSIS FOR THOSE VESSELS INCORPORATED INTO THE CUSTOM-MADE DEVICE PROCEDURE WERE PROVIDED. ADDITIONALLY, AORTIC DIAMETERS AND ANEURYSM DIAMETERS WERE PROVIDED. THE INDEPENDENT LABORATORY IDENTIFIED 40 % STENOSIS IN SMA. ALL ENDOGRAFT DEVICES WERE PATENT. A POST-PROCEDURAL CLINICAL ASSESSMENT WAS CONDUCTED REMOTELY ON (B)(6) 2024, 27 DAYS POST PROCEDURE. THE PATIENT WAS TAKING ANTITHROMBOTIC MEDICATIONS. SINCE THE STUDY PROCEDURE THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. A SIX-MONTH CLINICAL ASSESSMENT WAS COMPLETED IN PERSON ON (B)(6) 2025. THE PATIENT WAS TAKING ANTITHROMBOTIC MEDICATIONS. SINCE THE STUDY PROCEDURE THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. A COMPUTED TOMOGRAPHY SCAN (CT) WITH CONTRAST WAS COMPLETED ON (B)(6) 2025, 200 DAYS POST PROCEDURE. THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES WERE ALL PATENT WITHIN THE STENT AND WITHIN THE VESSEL. THE ENDOGRAFT DEVICES WERE PATENT. NO STENOSIS GREATER THAN 50% WAS IDENTIFIED IN ANY TREATED VESSEL. THE DIAMETER AT THE LOCATION OF MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 66 MM. THE ANEURYSM HAD NOT INCREASED IN DIAMETER MORE THAN 5 MM COMPARED TO THE POST-PROCEDURE CT MEASUREMENT. THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 15 MM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 15 MM. NO ENDOLEAK WAS PRESENT. NO SEPARATION OF COMPONENTS OCCURRED. THERE WAS NO EVIDENCE OF MIGRATION OF COMPONENTS MORE THAN OR EQUAL TO 10 MM. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THERE WAS NO EVIDENCE OF THROMBUS WITHIN A STUDY DEVICE. THE INDEPENDENT LABORATORY REVIEWED THE CT COMPLETED ON (B)(6) 2025. THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES WERE ALL PATENT WITHIN THE STENT AND WITHIN THE VESSEL. THE ENDOGRAFT DEVICES WERE PATENT. NO STENOSIS GREATER THAN 50% WAS IDENTIFIED IN ANY TREATED VESSEL. AORTIC DIAMETERS AT CUSTOM MADE GRAFT LOCATION, BRIDGING VESSELS, PROXIMAL SEAL ZONE, AND ANEURYSM SIZE WERE PROVIDED. NO SEPARATION OF COMPONENTS OCCURRED. THERE WAS NO EVIDENCE OF MIGRATION OF COMPONENTS MORE THAN OR EQUAL TO 10 MM. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THROMBUS WAS IDENTIFIED WITHIN THE COOK ZENITH FENESTRATED PLUS MAIN BODY (RPN: ZFEN+32-203-CI), UNIVERSAL DISTAL BODY (RPN: UNIBODY2-24-81-CI), ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT), AND THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT). THIS WAS AN INITIAL FINDING. NO TREATMENT WAS REPORTED FROM THE SITE. THE GRAFTS WERE DESCRIBED BY THE SITE TO BE PATENT, BUT THROMBUS BUILD UP WAS PRESENT IN THE GRAFTS. THE FOCUS OF THIS REPORT IS THE THROMBUS IDENTIFIED IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT) PLACED ON THE LEFT. ADDITIONAL REPORTS FOR THIS PATIENT HAVE BEEN SUBMITTED UNDER MFG. REPORT REFERENCE NUMBER:1820334-2024-01492.

    Description of Event or Problem · 0

    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
    414522 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55238 16240452 00827002552388

    Patients

    Seq Age Sex Outcome Treatment
    1