ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2025-00231
- Event Type
- Malfunction
- Date Received
- March 7, 2025
- Date of Event
- February 3, 2025
- Report Date
- July 1, 2025
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 00827002552425
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: D3 (E-MAIL), H6 - ANNEX A. INVESTIGATION ¿ EVALUATION. COOK WAS NOTIFIED THAT AN ENDOLEAK WAS IDENTIFIED 2-DAYS POST PROCEDURE. THE ENDOLEAK WAS DESCRIBED AS "¿ENDOLEAK BETWEEN CONTRALATERAL LIMB AND BIF DEVICE" THE COOK INCORPORATED PRODUCT INVOLVED IN THE REPORTED ENDOLEAK WAS A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. PRE-PROCEDURE IMAGING COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2024, 130 DAYS PRIOR TO THE PROCEDURE. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. PERCUTANEOUS ACCESS WAS GAINED IN THE RIGHT AND LEFT FEMORAL ARTERIES. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING STENTS PLACED: CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 9 MM IN DIAMETER AND 60 MM LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. A WILLIAM COOK AUSTRALIA CUSTOM MADE DEVICE (RPN: THORACO-ABDOMINAL-SIDE-BRANCH). A WILLIAM COOK AUSTRALIA ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT (RPN: UNIBODY-22-115) WAS PLACED. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT) WAS PLACED ON THE PATIENT'S LEFT. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT) WAS PLACED ON THE PATIENT'S RIGHT. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET VESSELS WERE PATENT. A TYPE 1B ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT WAS IDENTIFIED. THE PATIENT WAS EXTUBATED IN THE OPERATION ROOM AND DID NOT REQUIRE REINTUBATION. ON (B)(6) 2025, POST PROCEDURE A TYPE 1B DISTAL ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THE ¿TYPE 1B ENDOLEAK¿ INVOLVED THE WILLIAM COOK AUSTRALIA ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT AND THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-74-ZT), THE MOST PROXIMAL LIMB IN THE LEFT ILIAC ARTERY, THE ENDOLEAK WAS ALSO DESCRIBED AS "ENDOLEAK BETWEEN CONTRALATERAL LIMB AND BIF DEVICE" TWO DAYS POST PROCEDURE (B)(6) 2025), A FOLLOW UP CT WITH CONTRAST WAS COMPLETED. ALL STENT GRAFTS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A PERSISTENT TYPE 1B ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT WAS PRESENT. A SECONDARY INTERVENTION WAS NOT COMPLETED TO ADDRESS THE ENDOLEAK. THE PATIENT SPENT TWO NIGHTS IN THE INTENSIVE CARE UNIT. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), AN ANTICOAGULANT, AND A STATIN. COMPUTED TOMOGRAPHY (CT) IMAGING WAS COMPLETED AS WELL. FOUR DAYS AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND STATIN. THE FOCUS OF THIS REPORT IS THE ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT) REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI) AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS FOR A 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 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. MULTIPLE LARGE, PATENT LUMBAR ARTERIES, MURAL THROMBUS AND A PATENT INFERIOR MESENTERIC ARTERY MAY ALL PREDISPOSE A PATIENT TO TYPE II ENDOLEAKS. PATIENTS WITH UNCORRECTABLE COAGULOPATHY MAY ALSO HAVE AN INCREASED RISK OF TYPE II ENDOLEAK OR BLEEDING COMPLICATIONS. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING 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. 4.4 DEVICE SELECTION STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. 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 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. 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT, ANEURYSM RUPTURE AND DEATH, ENDOLEAK. 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. 8 PATIENT COUNSELING INFORMATION 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. FINAL ANGIOGRAM 1. POSITION ANGIOGRAPHIC CATHETER JUST ABOVE THE LEVEL OF THE RENAL ARTERIES. PERFORM ANGIOGRAPHY TO VERIFY THAT THE RENAL ARTERIES ARE PATENT AND THAT THERE ARE NO ENDOLEAKS. VERIFY PATENCY OF INTERNAL ILIAC ARTERIES. 2. CONFIRM THERE ARE NO ENDOLEAKS OR KINS AND VERIFY POSITION OF PROXIMAL GOLD RADIOPAQUE MARKERS. REMOVE THE SHEATHS, WIRES AND CATHETERS. NOTE: IF ENDOLEAKS OR OTHER PROBLEMS ARE OBSERVED, REFER TO THE SUGGESTED INSTRUCTIONS FOR USE FOR THE ZENITH AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENTS 12.1 GENERAL: 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. PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASES 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. IMAGING WAS PROVIDED FOR THE EVENT AND WAS REVIEWED BY A THORACIC AND VASCULAR SURGEON. THE REVIEWER INDICATED THAT THE TYPE OF ENDOLEAK WAS MOST LIKELY A 3A ENDOLEAK BETWEEN THE COOK UNIBODY DEVICE AND THE LEFT ILIAC LEG GRAFT. THE REVIEWER INDICATED THAT THE RE-BALLOONING THE UNIBODY-ZSLE OVERLAP AS WELL AS THE DISTAL ZSLE/COMMON ILIAC ARTERY SEAL ZONE WOULD HOPEFULLY FIX POSSIBLE CAUSES OF THE ENDOLEAK. BASED ON THE INFORMATION PROVIDED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. IT IS POSSIBLE THAT PATIENT¿S CALCIFIED AND TORTUOUS VESSELS AND INSUFFICIENT BALLOONING OF THE OVERLAP DURING THE PROCEDURE CONTRIBUTED TO THE FAILURE MODE. 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.
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 INFORMATION: B7. 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.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
COOK WAS NOTIFIED THAT AN ENDOLEAK WAS IDENTIFIED 2-DAYS POST PROCEDURE. THE ENDOLEAK WAS DESCRIBED AS "¿ENDOLEAK BETWEEN CONTRALATERAL LIMB AND BIF DEVICE" THE COOK INCORPORATED PRODUCT INVOLVED IN THE REPORTED ENDOLEAK WAS A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. PRE-PROCEDURE BLOOD LAB VALUES WERE PROVIDED FOR THE INVESTIGATION OF THE EVENT. PER-PROCEDURE IMAGING COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2024, 130 DAYS PRIOR TO THE PROCEDURE. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOT PRESCRIBED AN ANTI-PLATELET MEDICATION AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS GAINED IN THE RIGHT AND LEFT FEMORAL ARTERIES. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING STENTS PLACED: CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. THE ARTERY WAS ABLE TO BE REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 9 MM IN DIAMETER AND 60 MM LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY MAINTAINED WITH NORMAL END ARTERY PERFUSION. LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 59 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED OR EXTENDED WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY MAINTAINED WITH NORMAL END ARTERY PERFUSION. A WILLIAM COOK AUSTRALIA CUSTOM MADE DEVICE (RPN: THORACO-ABDOMINAL-SIDE-BRANCH). THE DEVICE WAS PLANNED FOR THIS PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE CUSTOM-MADE DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE CUSTOM-MADE DEVICE WAS CONSIDERED SUCCESSFUL. A WILLIAM COOK AUSTRALIA ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT (RPN: UNIBODY-22-115) WAS PLACED. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT) WAS PLACED ON THE PATIENT'S LEFT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. ILIAC ARTERY COMPONENT: A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT) WAS PLACED ON THE PATIENT'S RIGHT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET VESSELS WERE PATENT. A TYPE 1B ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT WAS IDENTIFIED. THE PATIENT WAS EXTUBATED IN THE OPERATION ROOM AND DID NOT REQUIRE REINTUBATION. ON (B)(6) 2025, POST PROCEDURE A TYPE 1B DISTAL ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THE TYPE 1B ENDOLEAK INVOLVED THE WILLIAM COOK AUSTRALIA ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT AND THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-74-ZT), THE MOST PROXIMAL LIMB IN THE LEFT ILIAC ARTERY, THE ENDOLEAK WAS ALSO DESCRIBED AS "ENDOLEAK BETWEEN CONTRALATERAL LIMB AND BIF DEVICE" TWO DAYS POST PROCEDURE (B)(6) 2025), A FOLLOW UP CT WITH CONTRAST WAS COMPLETED. ALL STENT GRAFTS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A PERSISTENT TYPE 1B ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT WAS PRESENT. A SECONDARY INTERVENTION WAS NOT COMPLETED TO ADDRESS THE ENDOLEAK. BLOOD LAB VALUES FOR THE HOSPITAL STAY WERE PROVIDED. THE PATIENT SPENT TWO NIGHTS IN THE INTENSIVE CARE UNIT. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), AN ANTICOAGULANT, AND A STATIN. COMPUTED TOMOGRAPHY (CT) IMAGING WAS COMPLETED AS WELL. FOUR DAYS AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND STATIN. THE FOCUS OF THIS REPORT IS THE ENDOLEAK ON THE LEFT MOST DISTAL ILIAC COMPONENT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT) ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY THE TYPE OF ENDOLEAK AS WELL AS ANY ADDITIONAL INTERVENTIONS THAT WERE COMPLETED TO ADDRESS THE ENDOLEAK. HOWEVER, NO INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
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 |
|---|---|---|---|---|---|---|---|
| 1213192 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55242 | 16330357 | 00827002552425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | CELIAC - VBX 8 X 59| COOK INCORPORATED RPN: ZSLE-13-56-ZT, LOT 1635579| COOK RPN:THORACO-ABDOMINAL-SIDE-BRANCH LOT AC11739| LEFT RENAL ARTERY - VBX 7 X 59| RIGHT RENAL ARTERY - VBX 7 X 59| SMA - BARD FLUENCY 9 X 60| W. COOK AUSTRALIA RPN: UNIBODY-2, LOT A1171880| WCA,RPN:THORACO-ABDOMINAL-SIDE-BRANCH, LOT 1173977 |