ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2025-00267
- Event Type
- Malfunction
- Date Received
- March 17, 2025
- Date of Event
- February 7, 2025
- Report Date
- July 9, 2025
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 00827002552388
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1: PHONE NUMBER: (B)(6). E3: OCCUPATION: PRINCIPAL INVESTIGATOR. H3: DEVICE EVALUATED BY MFG? DEVICE REMAINS IMPLANTED IN PATIENT. 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.
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: H6 (ANNEX A) INVESTIGATION-EVALUATION IT WAS REPORTED THAT A TYPE 3A ENDOLEAK WAS IDENTIFIED TWO DAYS POST PROCEDURE ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PATIENT UNDERWENT FENESTRATED ENDOVASCULAR REPAIR ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. AT THE TIME OF THE PROCEDURE, THE PATIENT WAS NOT TAKING ANTIPLATELET MEDICATION. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE BILATERAL FEMORAL ARTERIES. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. DURING THE PROCEDURE, THE PATIENT HAD COMPETITORS STENTS PLACED IN THE FOLLOWING VESSELS: SUPERIOR MESENTERIC ARTERY (SMA): 8 MM IN DIAMETER AND 22 MM LENGTH RIGHT RENAL ARTERY: 6 MM IN DIAMETER AND 22 MM IN LENGTH LEFT RENAL ARTERY: 5 MM IN DIAMETER AND 22 MM IN LENGTH LOWER LEFT RENAL ARTERY: 5 MM IN DIAMETER AND 27 MM IN LENGTH THE FOLLOWING COOK DEVICES WERE PLACED DURING THE PROCEDURE: WILLIAM COOK AUSTRALIA CUSTOM-MADE FENESTRATED DEVICE COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED ON THE PATIENT'S RIGHT. COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED ON THE PATIENT'S LEFT. SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE CUSTOM-MADE DEVICE (CMD) PROCEDURE. PROCEDURAL IMAGING (ANGIOGRAM) WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE, NO ENDOLEAKS WERE PRESENT. 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 DID NOT REQUIRE REINTUBATION. THE PATIENT REMAINED IN THE ICU FOR ONE DAY POST PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025, FOUR DAYS POST PROCEDURE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID, CLOPIDOGREL AND A STATIN AT DISCHARGE. THE PATIENT WAS NOT PRESCRIBED AN ANTICOAGULANT AT DISCHARGE. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2025, TWO DAYS POST PROCEDURE. THE PATIENT WAS STILL TAKING ACETYLSALICYLIC ACID, AN ANTIPLATELET, AND A STATIN. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS SINCE THE PROCEDURE. DURING THE CLINICAL ASSESSMENT, A COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED. ALL STENT GRAFTS WERE PATENT. NO STENOSIS GREATER THAN 50% OR OCCLUSION WAS IDENTIFIED IN THE SMA, RIGHT RENAL ARTERY, LEFT RENAL ARTERY, OR LEFT RENAL ACCESSORY ARTERY. A TYPE IIIA ENDOLEAK BETWEEN THE BIFURCATED AORTIC DEVICE AND THE MOST PROXIMAL ILIAC LIMB ON THE RIGHT WAS IDENTIFIED. NO SECONDARY INTERVENTION WAS COMPLETED TO TREAT THE ENDOLEAK. THERE IS NO EVIDENCE OF ANY STENT GRAFT INTEGRITY ISSUES AND ALL INTENDED SIDE BRANCH STENTS ARE INTACT. NO ADDITIONAL INTERVENTION WAS COMPLETED TO TREAT THE ENDOLEAK. THE NEXT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN IS PLANNED FOR 12 MONTHS POST PROCEDURE. THE SUBJECT OF THIS COMPLAINT IS THE TYPE 3A ENDOLEAK THAT WAS IDENTIFIED TWO DAYS POST PROCEDURE ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT). REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. 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 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 REPORTED FOR A RELATED FAILURE MODE. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND 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 ¿ 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 INVESTIGATION AND WAS REVIEWED BY A THORACIC AND VASCULAR SURGEON. THE REVIEWER CONFIRMED THE PRESENCE OF A TYPE 3A ENDOLEAK BETWEEN THE LEFT LIMB OF THE BIFURCATED GRAFT COMPONENT AND THE LEFT ILIAC LEG GRAFT (ZSLE). THE REVIEWER NOTED THAT THIS WAS PROBABLY DUE TO INADEQUATE BALLOON EXPANSION OF THE ZSLE INSIDE THE BIFURCATED GRAFT AND MOST LIKELY A USER PROBLEM RATHER THAN ANY FAULT OR FAILURE OF THE DEVICE. 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 IMAGE REVIEWER INDICATED THAT THIS WAS MOST LIKELY DUE TO INADEQUATE BALLOONING DURING THE PROCEDURE. 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.
IT WAS REPORTED THAT A TYPE 3A ENDOLEAK WAS IDENTIFIED TWO DAYS POST PROCEDURE ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. PRE-PROCEDURE IMAGING WAS COMPLETED ON (B)(6) 2024, 162 DAYS PRIOR TO THE PROCEDURE. THE PATIENT UNDERWENT FENESTRATED ENDOVASCULAR REPAIR ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. AT THE TIME OF THE PROCEDURE, THE PATIENT WAS NOT TAKING ANTIPLATELET MEDICATION. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE BILATERAL FEMORAL ARTERIES. AN ENDOVASCULAR ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE PROCEDURE. DURING THE PROCEDURE, THE PATIENT HAD THE FOLLOWING STENTS PLACED: SUPERIOR MESENTERIC ARTERY (SMA): A COMPETITOR'S STENT MEASURING 8 MM IN DIAMETER AND 22 MM LENGTH WAS PLACED. 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 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 5 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 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. LOWER LEFT RENAL ARTERY: A COMPETITOR'S STENT MEASURING 5 MM IN DIAMETER AND 27 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 FENESTRATED DEVICE WAS PLACED. NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE MAIN CMD DEVICE WERE EXPERIENCED. THE DELIVERY AND DEPLOYMENT OF THE MAIN CMD DEVICE WAS CONSIDERED SUCCESSFUL. ILIAC ARTERY COMPONENT: A COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG 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. ILIAC ARTERY COMPONENT: A COOK INCORPORATED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG 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. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 134 ML, CONTRAST DOSE: 1.5 ML/KG, FLUOROSCOPY TIME: 69 MINUTES, TOTAL GRAY USED: 3007 MGY, TOTAL DOSE AREA PRODUCT: 241 CGY*CM2, FUSION WAS USED DURING THE PROCEDURE. THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 0 ML. DURING THE PROCEDURE NO RED BLOOD CELLS/FRESH FROZEN, PLASMA/CRYOPRECIPITATE/PLATELETS/CELLSAVER WERE GIVEN. 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: 08:55, TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 09:20, TIME OF LAST ACCESS CLOSURE: 12:15, TIME LEAVES ROOM: 12:30, DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE): 175 MINUTES SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE CUSTOM-MADE DEVICE (CMD) PROCEDURE. PROCEDURAL IMAGING (ANGIOGRAM) WAS COMPLETED ON (B)(6) 2025. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE, NO ENDOLEAKS WERE PRESENT. 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 DID NOT REQUIRE REINTUBATION. THE PATIENT REMAINED IN THE ICU FOR ONE DAY POST PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025, FOUR DAYS POST PROCEDURE. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID, CLOPIDOGREL AND A STATIN AT DISCHARGE. THE PATIENT WAS NOT PRESCRIBED AN ANTICOAGULANT AT DISCHARGE. A ONE-MONTH CLINICAL ASSESSMENT WAS COMPLETED ON 07FEB2025, TWO DAYS POST PROCEDURE. THE PATIENT WAS STILL TAKING ACETYLSALICYLIC ACID, AN ANTIPLATELET, AND A STATIN. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS SINCE THE PROCEDURE. DURING THE CLINICAL ASSESSMENT, A COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED. ALL STENT GRAFTS WERE PATENT. NO STENOSIS GREATER THAN 50% OR OCCLUSION WAS IDENTIFIED IN THE SMA, RIGHT RENAL ARTERY, LEFT RENAL ARTERY, OR LEFT RENAL ACCESSORY ARTERY. A TYPE IIIA ENDOLEAK BETWEEN THE BIFURCATED AORTIC DEVICE AND THE MOST PROXIMAL ILIAC LIMB ON THE RIGHT WAS IDENTIFIED. NO SECONDARY INTERVENTION WAS COMPLETED TO TREAT THE ENDOLEAK. THERE IS NO EVIDENCE OF ANY STENT GRAFT INTEGRITY ISSUES AND ALL INTENDED SIDE BRANCH STENTS ARE INTACT. THE SUBJECT OF THIS COMPLAINT IS THE TYPE 3A ENDOLEAK THAT WAS IDENTIFIED TWO DAYS POST PROCEDURE ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. NO TREATMENT FOR THE ENDOLEAK WAS COMPLETED. AT THIS TIME, NO OTHER ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS PROVIDED ON 27MAR2025. NO ADDITIONAL INTERVENTION HAS BEEN COMPLETED TO TREAT THE ENDOLOEAK. THE NEXT COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN IS PLANNED FOR 12 MONTHS AFTER THE INTERVENTION.
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 |
|---|---|---|---|---|---|---|---|
| 1211053 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55238 | 16280258 | 00827002552388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | LEFT RENAL STENT: ADVANTA V12, 5X22 MM.| LOWER LEFT RENAL ARTERY STENT: ICOVER 5X27 MM.| RIGHT ILIAC: COOK ZSLE-16-56-ZT, LOT 16271819.| RIGHT RENAL STENT: ADVANTA V12, 6X22 MM.| SMA STENT: BENTLEY BEFLARED 8/10X22.| WCA RPN: AAA-FEN-BIFURCATED-GRAFT, LOT AC1173040. |