FDA Adverse Event Injury Summary report: N

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

MDR report key: 23369480 · Received October 23, 2025

Report

Report Number: 1820334-2025-01304
Event Type: Injury
Date Received: October 23, 2025
Date of Event: July 11, 2025
Report Date: February 17, 2026
Manufacturer: COOK INC
Product Code: MIH
UDI-DI: 00827002552463
PMA / PMN Number: P020018
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

E3: PRINCIPAL INVESTIGATOR. 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

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, H6 (ANNEX E). 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

ADDITIONAL INFORMATION: B5. 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 A PATIENT HAD STENOSIS OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-24-74-ZT) PLACED ON THE PATIENT'S RIGHT. IMAGING PROVIDED LATER CONFIRMED THROMBOSIS OF THE DEVICE AS WELL. THE PATIENT UNDERWENT AN ELECTIVE ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE ON (B)(6)2024 UNDER GENERAL ANESTHESIA. THE PATIENT WAS RECEIVING ANTIPLATELET MEDICATION THERAPY ACETYLSALICYLIC ACID (ASA) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. CUT DOWN ACCESS WAS REQUIRED FOR THE LEFT AXILLARY ARTERY. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING DEVICES PLACED: SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 9 MM IN DIAMETER AND 79 MM LENGTH SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 9 MM IN DIAMETER AND 50 MM LENGTH RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 59 MM IN LENGTH RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 50 MM IN LENGTH RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 50 MM IN LENGTH LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 79 MM IN LENGTH LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 50 MM IN LENGTH CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 10 MM IN DIAMETER AND 79 MM IN LENGTH CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 10 MM IN DIAMETER AND 50 MM IN LENGTH CUSTOM-MADE DEVICE (CMD) FROM WILLIAM COOK AUSTRALIA, ZENITH FENESTRATED GRAFT, RPN: THORACO-ABDOMINAL-SIDE-BRANCH WILLIAM COOK AUSTRALIA, ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT, RPN: UNIBODY-22-132 COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-24-90-ZT WAS PLACED ON THE RIGHT COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-24-74-ZT WAS PLACED ON THE RIGHT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-16-90-ZT, LOT WAS PLACED ON THE LEFT. WILLIAM COOK AUSTRALIA, ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, RPN: ZBIS-12-61-41 WAS PLACED ON THE LEFT. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WERE SUCCESSFUL. A PLANNED PROCEDURE WAS COMPLETED DURING THE PROCEDURE. AN ILIAC SIDE BRANCH WAS PLACED ON THE LEFT SIDE. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM WAS COMPLETED ON (B)(6) 2024. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET VESSELS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. NO ENDOLEAKS WERE PRESENT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET SIDE BRANCH STENTS WERE INTACT. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM. THE PATIENT WAS NOT REINTUBATED AND DID NOT REQUIRE A TRACHEOSTOMY. A SPINAL DRAIN WAS NOT PLACED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE STAYED TWO NIGHTS. AT DISCHARGE, THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, SEVEN DAYS POST PROCEDURE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AND A STATIN. DURING THE ONE-MONTH CLINICAL ASSESSMENT, COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. FOLLOW UP CT IMAGING WITH CONTRAST WAS COMPLETED ON (B)(6) 2024, SIX DAYS POST PROCEDURE. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. A NEW TYPE TWO ENDOLEAK WAS PRESENT. NO SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. THE MAXIMUM DIAMETER OF THE DISEASED AORTA OUTER WALL TO OUTER WALL WAS 60 MM. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A SIX-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, 162 DAYS POST PROCEDURE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA). SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. IMAGING WAS NOT COMPLETED DURING THE VISIT FOLLOW UP IMAGING (CT WITH CONTRAST) WAS COMPLETED ON (B)(6) 2025, 367 DAYS POST PROCEDURE. A 12-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, 401 DAYS POST PROCEDURE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA). SINCE THE LAST VISIT, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. CT IMAGING WAS COMPLETED DURING THE VISIT. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. THE MOST PROXIMAL LIMB ON THE RIGHT SIDE WAS NOT PATENT AND THE ILIAC LIMB EXTENSION ON THE RIGHT WAS NOT PATENT. A PERSISTENT TYPE TWO ENDOLEAK WAS PRESENT. NO SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. THE MAXIMUM DIAMETER OF THE DISEASED AORTA OUTER WALL TO OUTER WALL WAS 60 MM. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. ON (B)(6) 2025, 401 DAYS POST PROCEDURE STENOSIS GREATER THAN 50% IN THE RIGHT ILIAC WAS IDENTIFIED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025. ENDOVASCULAR TREATMENT WAS PERFORMED, AND THE BIFURCATED GRAFT WAS RELINED WITH COMPETITOR STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE FOCUS OF THIS REPORT IS THE STENOSIS AND THROMBOSIS OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-24-74-ZT PLACED ON THE PATIENT'S RIGHT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. IMAGING WAS PROVIDED FOR THE INVESTIGATION AND WAS REVIEWED BY A VASCULAR SURGEON. THE IMAGE REVIEWER INDICATED THAT BOTH OF THE DEVICES PLACED ON THE RIGHT WERE OCCLUDED. THE REVIEWER INDICATED THAT IT WAS DIFFICULT TO SEPARATE OUT BOTH OF THE DEVICES PLACED ON THE RIGHT AND SUSPECTED THERE WAS DOUBLING UP OF THE STENTS. THE BLOCKAGE BEGAN AT THE ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT, RPN: UNIBODY-22-132 ON THE RIGHT AND EXTENDED ALL THE WAY TO THE ILIAC ARTERY ON THE RIGHT. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT SHOULD BE NOTED THAT THIS DEVICE IS SUPPLIED VIA A ONE-DEVICE LOT. 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RECORDED DISCREPANCIES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER EVENTS REPORTED FOR THE RELATED FAILURE MODE. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: 4 WARNINGS AND PRECAUTIONS 4.1 GENERAL. ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. 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 SITE 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 GUIDE 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. THE ZENITH SPIRAL-Z ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS NOT RECOMMENDED IN PATIENT WHO CANNOT TOLERATE CONTRAST AGENTS NECESSARY FOR INTRAOPERATIVE AND POSTOPERATIVE FOLLOW-UP IMAGING. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. 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 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., ENDOLEAKS, 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 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. 4.5 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.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION A POTENTIAL ROOT CAUSE HAS BEEN TRACED TO PATIENT ANATOMY AND PRE-EXISTING CONDITIONS. THE IMAGE REVIEWER STATED ¿MOST LIKELY CAUSE OF FAILURE WOULD HAVE BEEN THE PERIPHERAL ARTERIAL DISEASE DISTAL TO THE ZSLE ON THE RIGHT SIDE. POOR OUTFLOW, WITH RESISTANCE, DUE TO THE PATIENT¿S ARTERIAL DISEASE.¿ 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 TOA DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

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CORRECTION: B5. 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.