ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2025-01385
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- August 27, 2025
- Report Date
- February 3, 2026
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 00827002552371
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY AND/OR REPORTABLE PRODUCT MALFUNCTION. IMAGING WAS PROVIDED FOR THE INVESTIGATION AND REVIEWED BY A VASCULAR SURGEON. THE IMAGE REVIEWER INDICATED THAT THERE WAS NO COMPRESSION OF THE PROXIMAL RIGHT ILIAC LIMB IN THE IMAGING (IMMEDIATE POST OPERATIVE COMPUTED TOMOGRAPHY) PROVIDED. 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.
COOK WAS NOTIFIED THAT COMPRESSION OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG PLACED ON THE RIGHT DURING A BRANCHED ENDOVASCULAR AORTIC REPAIR. THE COMPRESSION WAS IDENTIFIED IN PROCEDURAL IMAGING. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2024, 264 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 INCORPORATED INTO THE REPAIR. ALL THE ARTERIES MENTIONED WERE PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. 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 SPLENIC ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT. THE ARTERY WAS NOT STENOSED MORE THAN 50%. THE HEPATIC 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 AORTIC VALVE WAS UNKNOWN, AND IT IS UNKNOWN IF THE AORTIC ARCH WAS A BOVINE CONFIGURATION. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 58 MM. THE INTENDED PROXIMAL SEAL WAS ZONE 5: MID DESCENDING AORTA TO CELIAC THE LEFT AND RIGHT INTENDED DISTAL LANDING ZONE WAS ZONE 10: COMMON ILIAC ARTERIES. THE LOCATION OF THE PRIMARY TEAR WAS THE INNER AORTIC CURVE. THERE WAS NO EVIDENCE OF BLOOD PLURAL EFFUSION. PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, ONE DAY PRIOR TO THE PROCEDURE. THE PRIMARY INDICATION WAS CHRONIC AORTIC DISSECTION, TYPE A WITH PRIOR REPAIR. RELINING OF THE PRE-EXISTING SURGICAL GRAFT OR ENDOGRAFT WITH A FENESTRATED OR BRANCHED ENDOGRAFT AFTER PRIOR REPAIR HAD NOT BEEN COMPLETED. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOT PRESCRIBED ANTIPLATELET MEDICATION THERAPY AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING DEVICES PLACED: SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 135 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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 6 MM IN DIAMETER AND 135 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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 8 MM IN DIAMETER AND 120 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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. CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 135 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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 STEN WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 120 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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 STENTS WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. CELIAC ARTERY: A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 120 MM LENGTH WAS PLACED. THE ARTERY WAS NOT 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. LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 7 MM IN DIAMETER AND 120 MM IN LENGTH WAS PLACED. THE ARTERY WAS NOT 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 6 MM IN DIAMETER AND 135 MM IN LENGTH WAS PLACED. THE ARTERY WAS NOT 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 120 MM IN LENGTH WAS PLACED. THE ARTERY WAS NOT 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 135 MM IN LENGTH WAS PLACED. THE ARTERY WAS NOT 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. CUSTOM-MADE DEVICE (CMD) FROM WILLIAM COOK AUSTRALIA, ZENITH FENESTRATED GRAFT, RPN: THORACO-ABDOMINAL-SIDE-BRANCH WAS PLACED. THE DEVICE WAS PLANNED FOR THE PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF CMD DEVICE WAS CONSIDERED SUCCESSFUL. WILLIAM COOK AUSTRALIA GRAFT, RPN: PROXIMAL-THORACIC WAS PLACED IN THE DISTAL AORTA. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. WILLIAM COOK AUSTRALIA, ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT, RPN: UNIBODY-22-81 WAS PLACED. THE DEVICE WAS PLANNED FOR THE PATIENT. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE THORACIC PROXIMAL EXTENSION CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE CMD DEVICE WAS CONSIDERED SUCCESSFUL. WILLIAM COOK AUSTRALIA, ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, RPN: ZBIS-12-61-41 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-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. ILIAC COMPONENT: A COMPETITOR'S GRAFT 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. ILIAC COMPONENT: A COMPETITOR'S GRAFT 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. ILIAC COMPONENT: A COMPETITOR'S GRAFT 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. THE SPLENIC ARTERY WAS PERFORATED DURING THE PROCEDURE. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. PROCEDURAL IMAGING (ANGIOGRAM AND CONE BEAM COMPUTED TOMOGRAPHY (CT) WITHOUT CONTRAST) WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AND INTACT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET VESSELS WERE PATENT. ALL TARGET SIDE BRANCH STENTS WERE INTACT. A TYPE IC (SIDE BRANCH) ENDOLEAK ON THE ZBIS BRANCH WAS LEFT OPEN AS STAGING. DEVICE COMPRESSION ON THE MOST PROXIMAL RIGHT ILIAC LIMB WAS PRESENT. ADDITIONALLY, THERE WAS POSSIBLE COMPRESSION OF THE SMA STENT OBSERVED ON THE CONE BEAM CT. 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. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 295 ML CONTRAST DOSE: 4 ML/KG FLUOROSCOPY TIME: 101 MINUTES TOTAL GRAY USED: 1292 MGY TOTAL DOSE AREA PRODUCT: 154 CGY*CM2 FUSION WAS USED DURING THE PROCEDURE. THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 150 ML THE PATIENT WAS NOT GIVEN ANY RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATE, PLATELETS, OR CELL SAVER DURING THE PROCEDURE. CARDIAC OUTPUT REDUCTION WAS NOT USED. CARBON DIOXIDE FLUSHING WAS NOT USED. THE PROXIMAL SEAL ZONE WAS THE ENDOGRAFT. NO NEUROMONITORING WAS USED DURING THE PROCEDURE. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 08:26 TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 10:03 TIME OF LAST ACCESS CLOSURE: 14:49 TIME LEAVES ROOM: 15:30 DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 286 MINUTES SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE CMD PROCEDURE. ON (B)(6) 2025, POST PROCEDURE THE PATIENT HAD HYPERTENSION AND SPLENIC ARTERY BLEEDING WAS IDENTIFIED ON COMPUTED TOMOGRAPHY ANGIOGRAM (CTA). AN ENDOVASCULAR PROCEDURE WAS PERFORMED, AND THE SPLENIC ARTERY WAS COILED CENTRALLY TO THE SITE OF BLEEDING. THE SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. THE EVENT WAS STATED TO HAVE RESOLVED ON (B)(6) 2025 AND THE PATIENT RECOVERED/STABILIZED WITHOUT SEQUELAE. IT WAS THOUGHT THAT THE SPLENIC ARTERY WAS PERFORATED BY THE GUIDE WIRE DURING THE SPLENIC ARTERY STENT PLACEMENT AND THIS WAS POSSIBLY RELATED TO THE TREATED DISEASE AND UNDERLYING GENETIC VASCULOPATHY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE STAYED FIVE NIGHTS. THE PATIENT WAS NOT GIVEN PACKED RED BLOOD CELLS DURING THE OPERATION OR DURING THE HOSPITALIZATION. THE PATIENT WAS NOT DISCHARGED ON SUPPLEMENTAL OXYGEN. AT DISCHARGE, THE PATIENT WAS PRESCRIBED RIVAROXABAN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT UNDERWENT A SECOND STAGED PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025. THE SECOND STAGED PROCEDURE WAS TO COMPLETE THE INTERNAL ILIAC ARTERY IN THE ZBIS ON THE RIGHT. A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 59 MM LENGTH WAS PLACED WAS PLACED IN THE INTERNAL ILIAC ARTERY. 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 BRIDGING STENT WAS SUCCESSFUL. THE STENT PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE STAGED PROCEDURE. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAM AND CONE BEAM CT WITHOUT CONTRAST WAS COMPLETED ON (B)(6) 2025. THIS WAS 27 DAYS POST INDEX PROCEDURE. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL TARGET VESSELS WERE PATENT AND SIDE BRANCH STENTS WERE INTACT. A TYPE 1C ENDOLEAK WAS PRESENT AND IT WAS INDICATED THAT THE ZBIS BRANCH ON THE LEFT WAS OPEN AS STAGING. THE FOCUS OF THIS REPORT IS THE COMPRESSION OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG PLACED ON THE RIGHT, AS IDENTIFIED IN PROCEDURAL IMAGING COMPLETED ON (B)(6) 2025.
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2648988 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55237 | 16551798 | 00827002552371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | ATRIUM ADVANTA V12 12-16 MM 12X29MM 9F 120 CM| GORE VBX, 6 MM X 120 MM| GORE VBX, 6 MM X 135 MM| GORE VBX, 6 MM X 135 MM| GORE VBX, 8 MM X 135 MM| GORE VIABAHN 7 MM X 120 MM| GORE VIABAHN VBX, 11 X 79 MM X 135 CM, BXA117902E| GORE VIABAHN, 8 MM X 120 MM| GORE VIAHBAHN, 7 MM X 120 MM| GORE VIAHBAHN, 8 MM X 120 MM| MEDTRONIC VISI PRO 035, PXP35-07-27-135| OVATION IX FS042125-25| W. COOK AUS, RPN: PROXIMAL-THORACIC, LOT AC1182719| W. COOK AUS. RPN: UNIBODY-22-81, LOT A1171341| W. COOK AUS. RPN: ZBIS-12-61-41, LOT A1176959| WCA RPN: THORACO-ABDOMINAL-SIDE-BRANCH, AC118272 |