ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2025-01142
- Event Type
- Malfunction
- Date Received
- September 15, 2025
- Date of Event
- May 15, 2025
- Report Date
- November 20, 2025
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 00827002552432
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1: PRINCIPAL INVESTIGATOR H3 - DEVICE EVALUATED BY MFG? THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. CORRECTION: D4 - CATALOG #, LOT #, D10: NO CONCOMITANT PRODUCTS ARE KNOWN. INVESTIGATION ¿ EVALUATION THE PATIENT UNDERWENT A NEW FEVAR (FENESTRATED ENDOVASCULAR ANEURYSM REPAIR)/CUSTOM MADE DEVICE (CMD) PROCEDURE ON (B)(6) 2024. THERE WERE NO TECHNICAL DIFFICULTIES REPORTED, AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. ON (B)(6) 2025, 381 DAYS POST THE EVAR PROCEDURE, FOLLOW-UP IMAGING WAS COMPLETED. THE SITE REPORTED A NEW TYPE IB ENDOLEAK AT THE LEFT MOST DISTAL ILIAC COMPONENT AND A NEW TYPE II ENDOLEAK. NO SECONDARY INTERVENTION WAS PERFORMED. CLARIFICATION WITH THE SITE CONFIRMED THE TYPE IB ENDOLEAK IS FROM THE ZENITH FLEX DEVICE PLACED IN THE PRIOR EVAR+IBD (ENDOVASCULAR ANEURYSM REPAIR USING AN ILIAC BRANCH DEVICE) PROCEDURE AND DOES NOT REQUIRE ADDITIONAL TREATMENT BECAUSE THE SAC IS NOT PERFUSED. THERE ARE NO TYPE I ENDOLEAKS FROM THE FEVAR PROCEDURE AND FROM THE LIMBS IMPLANTED IN THE PROXIMAL IN SITU EVAR LIMBS. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE COMPLETED. HOWEVER, IMAGING WAS PROVIDED FOR EXPERT REVIEW. THE REVIEWER NOTED THAT, ¿THE ONLY EVIDENCE OF AN ENDOLEAK THAT I CAN SEE IS THE TYPE 1B IN THE L. EXTERNAL ILIAC ARTERY. CAN¿T CONFIRM THAT THIS IS A ZSLE, OR PART OF AN IBD. APART FROM THAT, THE MULTIPLE LAYERS OF OLD DEVICES AND NEW DEVICES MAKE IT IMPOSSIBLE TO SEE WITH ANY CERTAINTY IF ANYTHING ELSE IS GOING ON.¿ 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 DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE THE LACK OF LOT INFORMATION. COOK ALSO REVIEWED 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 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 10MM 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. POSTION 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. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE FAILURE ANALYSIS, 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, AND THE RESULTS OF THIS INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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.
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.
IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS IDENTIFIED ORIGINATING FROM THE LEFT MOST DISTAL ILIAC GRAFT LEG FOLLOWING PLACEMENT DURING A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (FEVAR). PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, ONE DAY PRIOR TO THE PROCEDURE. THE PRIMARY INDICATION WAS CHRONIC AORTIC DISSECTION, TYPE B. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITHOUT CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2024 (96 DAYS PRIOR TO THE PROCEDURE). THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, AND CELIAC ARTERY WERE NOT INCORPORATED INTO THE REPAIR. THE SUPERIOR MESENTERIC ARTERY (SMA) WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE RIGHT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE LEFT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE BILATERAL COMMON ILIAC AND INTERNAL ILIAC ARTERIES WERE PATENT. THE LEFT AND RIGHT VERTEBRAL ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 43 MM THE INTENDED PROXIMAL SEAL WAS ZONE 5: MID DESCENDING AORTA TO CELIAC THE LEFT AND RIGHT INTENDED DISTAL LANDING ZONE WAS ZONE 11: EXTERNAL ILIAC ARTERIES. THE PATIENT UNDERWENT AN ELECTIVE PROCEDURE ON (B)(6) 2024 UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED HEPARIN AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 80 ML, CONTRAST DOSE: 1.61 ML/KG, FLUOROSCOPY TIME: 45 MINUTES, TOTAL GRAY USED: 855 MGY, TOTAL DOSE AREA PRODUCT: 45 CGYCM2, FUSION WAS USED DURING THE PROCEDURE. THERE WAS NO ESTIMATED BLOOD LOSS DURING THE PROCEDURE. CARDIAC OUTPUT REDUCTION WAS NOT USED. CARBON DIOXIDE FLUSHING WAS USED. THE PROXIMAL SEAL ZONE WAS THE NATIVE AORTA. NO NEUROMONITORING WAS USED DURING THE PROCEDURE. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 15:52, TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 16:28, TIME OF LAST ACCESS CLOSURE: 18:52, TIME LEAVES ROOM: 19:15, DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 144 MINUTES. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING DEVICES PLACED: SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 27 MM LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED WITH A BARE METAL STENT. THE COVERED STENT WAS EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENTS WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 6 MM IN DIAMETER AND 28 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. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 6 MM IN DIAMETER AND 22 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS NOT RELINED DISTALLY WITH A BARE METAL STENT. THE COVERED STENT WAS EXTENDED DISTALLY 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. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 23 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. RIGHT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 6 MM IN DIAMETER AND 22 MM IN LENGTH WAS PLACED. THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENT WAS RELINED WITH A BARE METAL STENT. THE COVERED STENT WAS EXTENDED DISTALLY 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 CUSTOM-MADE DEVICE (CMD) FROM WILLIAM COOK AUSTRALIA, RPN: AAA-FEN-BIFURCATED-GRAFT, LOT AC1153519 ) WAS PLACED. THE DEVICE WAS PLANNED FOR THE PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE FENESTRATED BIFURCATED CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE THORACIC PROXIMAL EXTENSION CMD DEVICE WAS CONSIDERED SUCCESSFUL. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-16-56-ZT WAS PLACED ON THE RIGHT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. COOK INCORPORATED, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-20-90-ZT WAS PLACED ON THE LEFT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. DISTAL AORTIC DEVICE: COMPETITOR¿S GRAFT. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THIS DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. COOK ANCILLARY DEVICES WERE USED IN THE PROCEDURE. THE DEVICES SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED. NO DEVICE DEFICIENCIES WERE IDENTIFIED. DURING THE PROCEDURE THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE CELIAC STENT WAS NOT SUCCESSFUL. THE CELIAC TRUNK WAS NOT CATHETERIZED DUE TO THROMBOSIS OF THE OSTIA. THE DECISION WAS MADE TO OCCLUDE THE CMD FENESTRATION WITH A CUFF. PROCEDURAL IMAGING (ANGIOGRAM) WAS COMPLETED ON (B)(6) 2024. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AND INTACT AT THE CONCLUSION OF THE PROCEDURE. THE CELIAC ARTERY WAS NOT PATENT; ALL OTHER TARGET VESSELS WERE PATENT. NO ENDOLEAKS WERE PRESENT AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. 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 NOT GIVEN PACKED RED BLOOD CELLS DURING THE OPERATION OR DURING THE HOSPITALIZATION. THE PATIENT WAS NOT DISCHARGED ON SUPPLEMENTAL OXYGEN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024, THREE DAYS POST PROCEDURE. AT DISCHARGE, THE PATIENT WAS PRESCRIBED RIVVAROXABAN AND A STATIN. A ONE MONTH FOLLOW UP CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024, FIFTY-ONE DAYS POST PROCEDURE. THE LEFT AND RIGHT ANKLE BRACHIAL INDEX WAS NOT ASSESSED. 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 ASSESSMENT. BLOOD TESTS WERE NOT COMPLETED. FOLLOW UP IMAGING IN THE FORM OF A COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2024, 44 DAYS POST PROCEDURE. NO STENOSIS GREATER THAN 20% OR OCCLUSION WAS NOTED IN THE SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. NO ENDOLEAKS WERE PRESENT. NO PROGRESSION OF DISSECTION WAS DETECTED. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES AND ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A SIX-MONTH CLINICAL ASSESSMENT WAS NOT COMPLETED AS IT WAS NOT STANDARD OF CARE. FOLLOW UP CT IMAGING WITH CONTRAST WAS COMPLETED ON (B)(6) 2025, 381 DAYS POST PROCEDURE. NO STENOSIS GREATER THAN 20% OR OCCLUSION WAS NOTED IN THE SMA, RIGHT RENAL, OR LEFT RENAL ARTERIES. ALL STENT GRAFTS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES AND ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A TYPE 1B ENDOLEAK WAS IDENTIFIED ON THE MOST DISTAL ILIAC COMPONENT PLACED ON THE LEFT. ADDITIONALLY, A NEW TYPE 11 ENDOLEAK WAS IDENTIFIED. A SECONDARY INTERVENTION WAS NOT PERFORMED TO TREAT THE ENDOLEAK. A TWELVE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, 402 DAYS POST PROCEDURE. THE LEFT AND RIGHT ANKLE BRACHIAL INDEX WAS NOT ASSESSED. 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 ASSESSMENT. BLOOD TESTS WERE NOT COMPLETED. THIS REPORT CAPTURES THE TYPE 1B ENDOLEAK THAT WAS IDENTIFIED ON THE MOST DISTAL ILIAC COMPONENT PLACED ON THE LEFT DURING THE CT ON (B)(6) 2025.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
THE PATIENT HAD PRIOR AORTIC SURGERY, ENDOVASCULAR AORTIC REPAIR (EVAR). THIS WAS COMPLETED PRIOR TO THE CUSTOM-MADE DEVICE PROCEDURE COMPLETED ON (B)(6) 2024.
ADDITIONAL INFORMATION WAS PROVIDED ON 16OCT2025. THE FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE WAS COMPLETED TO ADDRESS AN AORTIC DISSECTION ABOVE THE CELIAC TRUNK. THE COMPETITOR'S TUBE WAS PLACED WHEN THE PATIENT WAS IN ANOTHER INSTITUTION. THE PATIENT HAD TWO ILIAC BRANCH DEVICES (IBD) IN SITU ON BOTH SIDES PRIOR TO THE FEVAR. THE TYPE 1B ENDOLEAK IS FROM THE PRIOR ENDOVASCULAR AORTIC REPAIR (EVAR) AND ILIAC BRANCH DEVICE (IBD) PROCEDURE AND DOES NOT REQUIRE ADDITIONAL TREATMENT BECAUSE THE SAC IS NOT PERFUSED. THERE ARE NO TYPE 1 ENDOLEAKS FROM THE FEVAR PROCEDURE AND FROM THE LIMBS IMPLANTED IN THE PROXIMAL IN SITU EVAR LIMBS. WE HAD INITIALLY PLANNED TO IMPLANT 6-22 AND 6-28 STENTS IN THE RIGHT AND LEFT RENAL STENTS RESPECTIVELY. OUR SIZING WAS INCORRECT, BOTH STENTS SERE RELINED DISTALLY, WITH A 6-22 AND A 7-23 IN THE RIGHT AND LEFT RENAL ARTERIES RESPECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1778828 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55243 | UNKNOWN | 00827002552432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | CINC HNBR5.0-35-125-P-NS-VANSCHIE3, LOT 15935921| CINC HNBR5.0-35-125-P-NS-VANSCHIE4, LOT 15937655| COOK INC. CODA-2-9.0-35-120-32, LOT 15892989| COOK INC. HNBR5.0-38-80-P-NS-VS, LOT 15942318| COOK INC. RPN: JCDS-2022-EDS-HC, LOT 15941261| COOK INC. RPN:THSCF-35-260-1.5-ROSEN, LOT 15812168| COOK INC. THSCF-35-260-1.5-ROSEN, LOT 15868548| COOK INC. THSCF-35-260-1.5-ROSEN, LOT 15868548 X 2| COOK INCORPORATED (CINC) RFPC-35-260, LOT 15669579| COOK INCORPORATED RPN: ZSLE-16-56-ZT, LOT 15488766| ENDURANT II ABDOMINAL TUBE| W COOK AUS AAA-FEN-BIFURCATED-GRAFT, LOT AC1153519 |