FDA Adverse Event Injury Summary report: N

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

MDR report key: 23268938 · Received October 10, 2025

Report

Report Number: 1820334-2025-01240
Event Type: Injury
Date Received: October 10, 2025
Date of Event: September 12, 2025
Report Date: January 8, 2026
Manufacturer: COOK INC
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
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 OF A KINK AND STENOSIS OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT) THAT WAS PLACED ON THE PATIENT¿S RIGHT. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) ON (B)(6) 2024 UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING COOK DEVICES PLACED: A CUSTOM-MADE DEVICE (CMD) FROM WILLIAM COOK AUSTRALIA, ZENITH FENESTRATED GRAFT, (RPN: FEN-THORACO-ABDOMINAL-GRAFT) WAS PLACED. WILLIAM COOK AUSTRALIA, ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, (RPN: ZBIS-10-45-41) WAS PLACED ON THE RIGHT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-20-39-ZT) WAS PLACED ON THE LEFT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-24-56-ZT) WAS PLACED ON THE LEFT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-13-56-ZT) WAS PLACED ON THE RIGHT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-13-39-ZT) WAS PLACED ON THE RIGHT. WILLIAM COOK AUSTRALIA, ZENITH FENESTRATED GRAFT, RPN, (FEN-THORACO-ABDOMINAL-GRAFT) WILLIAM COOK AUSTRALIA, ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT, (RPN: UNIBODY-24-81) COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-13-56-ZT) WAS PLACED ON THE RIGHT. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, (RPN: ZSLE-24-56-ZT) WAS PLACED ON THE LEFT. WILLIAM COOK AUSTRALIA, ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, (RPN: ZBIS-12-45-58) WAS PLACED ON THE RIGHT. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WERE SUCCESSFUL. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE CMD PROCEDURE. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE CMD PROCEDURE. 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. ALL TARGET SIDE BRANCH STENTS WERE INTACT. A TYPE TWO ENDOLEAK WAS PRESENT. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM. THE PATIENT WAS NOT REINTUBATED AND DID NOT REQUIRE A TRACHEOSTOMY. A SPINAL DRAIN WAS PLACED PRE-OPERATIVELY, TWO DAYS PRIOR TO THE PROCEDURE. NO COMPLICATIONS WERE EXPERIENCED WITH THE SPINAL DRAIN. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE STAYED THREE NIGHTS. ON (B)(6) 2024, THREE DAYS POST PROCEDURE THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI). ANTIBIOTICS WERE ADMINISTERED. THE BLADDER CATHETER WAS LEFT IN THE BLADDER. ON (B)(6) 2024, FOUR DAYS POST PROCEDURE THE PATIENT HAD HYPOTONIA DUE TO A DECREASED HEMOGLOBIN VALUE. TWO UNITS OF ERYTHROCYTE CONCENTRATES WERE ADMINISTERED. THIS WAS CAUSALLY RELATED TO THE PROCEDURE DUE TO BLOOD LOSS DURING THE PROCEDURE THAT REQUIRED A TRANSFUSION POST PROCEDURE. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS AFTER THE PROCEDURE OR BEFORE DISCHARGE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND A STATIN AT DISCHARGE. THE PATIENT WAS NOT DISCHARGED ON SUPPLEMENTAL OXYGEN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. A ONE MONTH FOLLOW UP CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, SEVEN DAYS POST PROCEDURE. BILATERAL ANKLE BRACHIAL INDEX WAS NOT ASSESSED. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), AN ANTICOAGULANT, AND A STATIN. DURING THE ONE MONTH CLINICAL ASSESSMENT, COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. A REVIEW OF THE FOLLOW UP IMAGING (CT WITH CONTRAST) DATED (B)(6) 2024, FOUR DAYS POST PROCEDURE WAS COMPLETED. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. NO ENDOLEAKS WERE PRESENT. THE MAXIMUM DIAMETER OF THE DISEASED AORTA OUTER WALL TO OUTER WALL WAS 56 MM. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A REVIEW OF THE FOLLOW UP IMAGING (CT WITH CONTRAST) DATED (B)(6) 2025,136 DAYS POST PROCEDURE WAS COMPLETED. NO OCCLUSION OR STENOSIS GREATER THAN 50% WAS NOTED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. THE MAXIMUM DIAMETER OF THE DISEASED AORTA OUTER WALL TO OUTER WALL WAS 53 MM. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A NEW TYPE 2 ENDOLEAK WAS PRESENT. A KINK WAS IDENTIFIED IN THE RIGHT ILIAC LIMB EXTENSION. A SECONDARY INTERVENTION WAS PLANNED TO TREAT THE TYPE 2 ENDOLEAK AND THE KINK. A SIX-MONTH FOLLOW UP CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, 174 DAYS POST PROCEDURE. BILATERAL ANKLE BRACHIAL INDEX WAS NOT ASSESSED. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AND A STATIN. DURING THE SIX-MONTH CLINICAL ASSESSMENT, COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025. IMAGING RESULTS FROM THE SIX-MONTH IMAGING IDENTIFIED DEVICE STENOSIS, A TYPE 2 ENDOLEAK, AND A DEVICE KINK. ON (B)(6) 2025, 357 DAYS POST PROCEDURE, A SECONDARY INTERVENTION REQUIRED TO TREAT THE TYPE 2 ENDOLEAK AND THE KINKING AND STENOSIS IN THE RIGHT ILIAC LIMB. SURGICAL CUT DOWN OF THE LEFT GROIN WITH ARTERIAL REPAIR WAS COMPLETED. THE CLOSURE DEVICE HAD FAILED AND REQUIRED A DIRECT SUTURE. COMPETITOR¿S STENTS WERE USED IN THE ILIAC ARTERIES TO PERFORM THE KISSING TECHNIQUE AND WERE PLACED APPROXIMATELY TWO CM ABOVE THE PROSTHESIS BIFURCATION. AN ADDITIONAL COMPETITOR¿S STENT WAS PLACED IN THE RIGHT ILIAC LEG GRAFT. THE TYPE 2 ENDOLEAK WAS AT THE LEVEL OF ¿THE NEO-BIFURCATION¿ FROM A LUMBAR ARTERY PAIR. THE SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE FOCUS OF THIS REPORT IS THE KINK AND STENOSIS ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG PLACED ON THE RIGHT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. HOWEVER, IMAGING WAS PROVIDED AND WAS REVIEWED BY A VASCULAR SURGEON. THE IMAGE REVIEWER INDICATED ¿THIS PATIENT HAD A PREVIOUS TEVAR (CLEARLY VISIBLE ON THE IMAGING) AND HAD ALSO HAD A FEMORO-FEMORAL BYPASS PREVIOUSLY, WHICH IS USUALLY DONE FOR AN ILIAC ARTERY OCCLUSION. HOWEVER, I COULD NOT SEE ANY EVIDENCE OF THIS FEM-FEM BYPASS ON ANY OF THE IMAGING SERIES, NOT EVEN ON THE PRE-PROCEDURAL IMAGES. THERE IS SOME SCATTER ARTIFACT ON ALL THE IMAGING SERIES DUE TO BILATERAL HIP REPLACEMENTS, BUT NO SIGN OF A FEM-FEM CROSSOVER BYPASS. THE OTHER FACTOR THAT IS APPARENT ON THE PRE-OP IMAGING IS THAT THE RIGHT COMMON ILIAC ARTERY, IMMEDIATELY BELOW THE AORTIC BIFURCATION, IS VERY ACUTELY ANGLED, AND THIS IS THE SITE OF THE ZSLE KINK SEEN ON THE POST-OP IMAGING. ON THE 1-MONTH POST-OP IMAGING, THAT SEVERE ANGULATION HAS BEEN STRAIGHTENED OUT A LITTLE, WITH THE ZSLE ACTING AS A SCAFFOLDING TO MAINTAIN PATENCY. BUT ON THE 6-MONTH SCANS, THIS ACUTE ANGULATION HAS RECURRED, PRESUMABLY DUE TO ONGOING PRESSURE AND TORTUOSITY OF THE PATIENT¿S ANATOMY. THIS KINK IN THE ZSLE IS CAUSING A SIGNIFICANT STENOSIS, AND I NOTE THAT A SECONDARY INTERVENTION WAS NEEDED TO RESTORE ADEQUATE BLOOD FLOW TO THE RIGHT LOWER LIMB. THIS CONSISTED OF ¿KISSING STENTS¿ IN BOTH COMMON ILIAC ARTERIES, AND APPARENTLY WITH GOOD RESULTS. SUMMARY: KINK IN THE RIGHT ZSLE DEVICE CAUSED BY ACUTE ANGULATION OF PATIENT¿S RIGHT COMMON ILIAC ARTERY (PATIENT ANATOMY), LEADING TO SIGNIFICANT STENOSIS. TREATED WITH SECONDARY INTERVENTION WITH GOOD RESULT. NOT DUE TO ANY FAULT OR FAILURE OF ANY OF THE DEVICES, BUT MAINLY DUE TO PATIENT ANATOMY AND THE ACUTE ANGULATION OF THE RIGHT COMMON ILIAC ARTERY SEEN ON THE PRE-OP IMAGING. ADDITIONALLY, 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT AND THE RELATED SUBASSEMBLY LOTS SHOWED NO DISCREPANCIES. IT SHOULD BE NOTED THAT THIS DEVICE IS SUPPLIED VIA A ONE-DEVICE LOT. THEREFORE, COOK CONCLUDES THAT THE COMPLAINT DEVICE WAS MANUFACTURED PER SPECIFICATION. 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 ¿ 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. THESES 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 SHEATHS. 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. ¿ 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., 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 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 BEND OR KINK THE DELIVERY SYSTEM. DOING SO MAY CAUSE DAMAGE TO THE DELIVERY SYSTEM AND THE ZENITH SPIRAL-Z AAA ILIAC LEG GRAFT. ¿ 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. ¿ FLUOROSCOPY SHOULD BE USED DURING INTRODUCTION AND DEPLOYMENT TO CONFIRM PROPER OPERATION OF THE DELIVERY SYSTEM COMPONENT, PROPER PLACEMENT OF THE GRAFT, AND DESIRED PROCEDURAL OUTCOME. 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 ¿ 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 ANATOMICAL SUITABILITY FOR ENDOVASCULAR 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. ¿ 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) 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 THE 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 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). 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 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. IN THIS CIRCUMSTANCE, A NON-CONTRAST CT SHOULD BE PERFORMED TO USE IN CONJUNCTION WITH THE ULTRASOUND. ULTRASOUND MAY BE A LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. THE CAUSE IN THIS CASE IS NOT KNOWN, PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE IMAGE REVIEWER STATED, ¿KINK IN THE RIGHT ZSLE DEVICE CAUSED BY ACUTE ANGULATION OF PATIENT¿S RIGHT COMMON ILIAC ARTERY (PATIENT ANATOMY), LEADING TO SIGNIFICANT STENOSIS. TREATED WITH SECONDARY INTERVENTION WITH GOOD RESULT. NOT DUE TO ANY FAULT OR FAILURE OF ANY OF THE DEVICES, BUT MAINLY DUE TO PATIENT ANATOMY AND THE ACUTE ANGULATION OF THE RIGHT COMMON ILIAC ARTERY SEEN ON THE PRE-OP IMAGING.¿ THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE ASSOCIATED 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 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.

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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

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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

ADDITIONAL INFORMATION/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.