ENDOVASCULAR DILATOR SET
Report
- Report Number
- 1820334-2025-00161
- Event Type
- Injury
- Date Received
- February 20, 2025
- Date of Event
- January 13, 2025
- Report Date
- August 20, 2025
- Manufacturer
- COOK INC
- Product Code
- DRE
- UDI-DI
- 00827002528345
- PMA / PMN Number
- K210734
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
INVESTIGATION ¿ EVALUATION: COOK WAS INFORMED OF AN EVENT INVOLVING AN 85-YEAR-OLD MALE PATIENT WITH FOCAL DISSECTION AT THE RIGHT COMMON FEMORAL ARTERY ON POST-PROCEDURE IMAGING, IDENTIFIED BY THE STUDY¿S CORE LAB. THE IPSILATERAL ACCESS SITE WAS THE RIGHT FEMORAL AND THE RIGHT ILIAC LEG GRAFT IS THE IPSILATERAL LEG GRAFT. HOWEVER, CONTRIBUTION/CAUSAL FACTORS ARE NOT KNOWN. THE OPERATIVE REPORT REGARDING ACCESS ARE AS FOLLOWS: ¿UNDER ULTRASOUND GUIDANCE, A MICRO PUNCTURE NEEDLE AND WIRE WERE INTRODUCED INTO THE RIGHT COMMON FEMORAL ARTERY. FLUOROSCOPY CONFIRMED WIRE WITHIN THE AORTOILIAC SYSTEM. THE MICRO PUNCTURE SHEATH WAS INSERTED FOLLOWED BY A 0.035 GUIDEWIRE. THE SOFT TISSUE AND FASCIA WERE SPREAD WITH A CLAMP. TWO SUTURE MEDIATED CLOSURE SYSTEMS WERE SEQUENTIALLY INSERTED AND THEIR SUTURE SECURED WITH CLAMPS. AN 8-F SHEATH WAS THEN INSERTED. ATTENTION WAS THEN TURNED TO THE LEFT GROIN.¿ THERE IS NO MENTION OF ANY ISSUE REGARDING THE RIGHT FEMORAL ARTERY/ACCESS SITE IN THE PROCEDURAL REPORT. THERE IS MENTION OF A SUTURE MEDIATED CLOSURE SYSTEM FAILURE IN THE LEFT COMMON FEMORAL BUT WOULD BE OF NO CONSEQUENCE TO THE RIGHT. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, 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 PERFORMED. HOWEVER, MEDICAL IMAGING WAS PROVIDED TO THE MANUFACTURER FOR EXPERT IMAGE REVIEW. A NEW FOCAL DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY (IPSILATERAL ACCESS) IS SEEN ON THE POST-OP CT FOLLOWING ENDOVASCULAR AAA REPAIR WITH ZFEN+ DEVICE. THE DISSECTION IS LIKELY PROCEDURE RELATED BUT NOT NECESSARILY RELATED TO THE DILATOR DEVICE. THIS IS A KNOWN COMPLICATION WITH ANY ARTERIAL ACCESS AND COULD HAVE OCCURRED DURING THE ARTERIAL PUNCTURE, INITIAL WIRE INSERTION, PLACEMENT OF THE SUTURE CLOSURE DEVICES, OR PASSING OF THE DILATOR OR INTRODUCER SHEATH. THE PATIENT IS A SMOKER, AND THIS COULD INCREASE THE FRAGILITY OF HIS VESSELS AND INTIMA. ANOTHER FOCAL DISSECTION IS SEEN ON THE PRE-OP CT IN THE EXTERNAL ILIAC ARTERY WITH A HISTORY OF PCI, SO HIS VESSEL DISEASE COULD BE A CONTRIBUTING FACTOR. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT APPROPRIATE INSPECTIONS ARE IN PLACE RELATIVE TO THE REPORTED DEVICE FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO RELATED NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK WAS ABLE TO REVIEW PRODUCT LABELING. THE DEVICE WAS PACKAGED WITH IFU T_EDS_REV0. THE IFU INCLUDES THE FOLLOWING, WARNING, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. WARNINGS ¿ DO NOT USE IF ANY SIGN OF PRODUCT DAMAGE IS VISIBLE. ¿ DO NOT ALTER THE DEVICE IN ANY WAY. ¿ THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. ¿ AVOID MANIPULATING OR WITHDRAWING THE WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE OR SHEAR MATERIAL FROM THE WIRE GUIDE. ¿ ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE. PRECAUTIONS ¿ THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE CONSIDERED WHEN SELECTING THE DILATOR SIZE. ¿ IF RESISTANCE IS ENCOUNTERED DURING DILATOR MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING FURTHER. POTENTIAL ADVERSE EVENTS ¿ PERFORATION OR LACERATION OF THE VESSEL WALL INSTRUCTIONS FOR USE 2.INTRODUCE AN ACCESS NEEDLE INTO TARGET ANATOMY. 3.INTRODUCE A WIRE GUIDE THROUGH THE NEEDLE AND INTO THE TARGET ANATOMY. 4.WITHDRAW THE NEEDLE, LEAVING THE WIRE GUIDE IN PLACE. 5.SMOOTHLY ADVANCE THE DILATOR OVER WIRE GUIDE TO THE DESIRED PLACEMENT WITHIN THE TRACT. 6.REMOVE DILATOR FORM TRACT WHILE MAINTAINING THE POSITIONING OF THE WIRE GUIDE WITHIN THE ANATOMY FOR ADVANCEMENT OF NEXT PRODUCT TO THE SELECTED PLACE WITHIN THE TRACT. AFTER REVIEWING THE IFU, COOK HAS CONCLUDED THE DEVICE LABELING CONTAINS APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS TO THE USER RELATED TO THE REPORTED FAILURE. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DHR, DEVICE FAILURE ANALYSIS, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING, SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXPERT REVIEW OF MEDICAL IMAGING PROVIDED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. THE IMAGE REVIEWER STATED, ¿THE DISSECTION IS LIKELY PROCEDURE RELATED BUT NOT NECESSARILY RELATED TO THE DILATOR DEVICE. THIS IS A KNOWN COMPLICATION WITH ANY ARTERIAL ACCESS AND COULD HAVE OCCURRED DURING THE ARTERIAL PUNCTURE, INITIAL WIRE INSERTION, PLACEMENT OF THE SUTURE CLOSING DEVICES, OR PASSING OF THE DILATOR OR INTRODUCER SHEATH. THE PATIENT IS A SMOKER, AND THIS COULD INCREASE THE FRAGILITY OF HIS VESSELS AND INTIMA.¿ 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.
COOK WAS NOTIFIED THAT A DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY WAS IDENTIFIED THIRTY-FIVE DAYS AFTER THE USE OF COOK PRODUCTS IN A FOUR-VESSEL FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR). THE PATIENT UNDERWENT PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2024, 48 DAYS PRIOR TO THE PROCEDURE. THE CT SCAN WAS COMPLETED BY THE SITE AND IDENTIFIED THE FOLLOWING: PER PATIENT ECRF: PRE-PROCEDURE IMAGING WAS COMPLETED ON (B)(6) 2024, 48 DAYS PRIOR TO THE PROCEDURE. THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR THROMBUS. HOWEVER MILD CALCIFICATION WAS PRESENT. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE RIGHT COMMON ILIAC ARTERY LEFT COMMON ILIAC ARTERY, RIGHT EXTERNAL ILIAC ARTERY, LEFT EXTERNAL ILIAC ARTERY, RIGHT FEMORAL ARTERY, LEFT FORMAL ARTERY DID NOT HAVE ANY OCCLUSIVE DISEASE. THE RIGHT COMMON ILIAC ARTERY HAD MILD CALCIFICATION. THE LEFT COMMON ILIAC ARTERY HAD MILD CALCIFICATION. THE RIGHT ILIAC ARTERY TORTUOSITY WAS DESCRIBED TO BE MILD. THE LEFT ILIAC ARTERY TORTUOSITY WAS DESCRIBED TO BE MILD. THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 55 MM. THE LENGTH OF THE SUITABLE PROXIMAL SEAL ZONE WAS 40 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 26 MM. THE DIAMETER OF AORTA AT THE LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 24 MM. THE % CHANGE IN SEAL ZONE DIAMETER THROUGHOUT THE LENGTH OF THE SEAL ZONE WAS 7.69. THE LENGTH FROM LOWEST TARGETED VESSEL (MOST INFERIOR ASPECT) TO THE AORTIC BIFURCATION WAS 85 MM. THE ANGULATION BETWEEN INFRA-RENAL AORTA AND ANEURYSM CENTER LINE WAS 10 DEGREES. THE MAXIMUM ANGULATION ABOVE THE INFRA-RENAL AORTA (WITHIN REGION OF ZFEN+ AND DELIVERY SYSTEM WAS 32 DEGREES. THE PERCENTAGE OF STENOSIS WAS LESS THAN 50% FOR THE CELIAC, SMA, RIGHT RENAL, AND LEFT RENAL ARTERIES. THE DIAMETER OF THE CELIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 8.4 MM. THE LENGTH FROM THE CELIAC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 25 MM. THE DIAMETER OF THE SUPERIOR MESENTERIC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 7.8 MM. THE LENGTH FROM THE SUPERIOR MESENTERIC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 45 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 5.4 MM. THE LENGTH FROM THE RIGHT RENAL OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 40 MM. THE DIAMETER OF THE LEFT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 5.4 MM. THE LENGTH FROM THE LEFT RENAL OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 33 MM. THE LENGTH FROM THE OSTIUM OF THE RIGHT ILIAC ARTERY TO THE FIRST MAJOR BIFURCATION WAS 38 MM. THE DIAMETER OF THE RIGHT ILIAC ARTERY AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 13 MM. THE LENGTH FROM THE OSTIUM OF THE RIGHT ILIAC ARTERY TO THE FIRST MAJOR BIFURCATION WAS 57 MM. THE DIAMETER OF THE LEFT ILIAC ARTERY AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 13 MM. THE LENGTH FROM THE OSTIUM OF THE LEFT ILIAC ARTERY TO THE FIRST MAJOR BIFURCATION WAS 63 MM. THE LOCATION OF THE INTENDED DISTAL LANDING ZONE MAINTAINED THE PATENCY OF THE INTERNAL ILIAC ARTERIES. NO STENOSIS WAS PRESENT IN THE LEFT OR RIGHT ILIAC ARTERY. AN INDEPENDENT LABORATORY REVIEWED THE PRE-OPERATIVE IMAGING AND IDENTIFIED THE FOLLOWING: THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR THROMBUS. HOWEVER MILD CALCIFICATION WAS PRESENT. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE LENGTH FROM THE MOST PROXIMAL ASPECT OF THE CELIAC ARTERY TO THE MOST PROXIMAL EXTENT OF THE ANEURYSM WAS 42.8 MMM. THE POSITION OF THE PROXIMAL EXTENT OF ANEURYSM WAS DISTAL TO THE CELIAC ARTERY. THE LENGTH OF THE PROXIMAL SEAL ZONE WAS 81.6 MM. THE DIAMETER OF THE AORTA AT LOCATION OF MAXIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 27.0 MM. THE DIAMETER OF AORTA AT THE LOCATION OF MINIMUM DIAMETER OVER LENGTH OF PROXIMAL SEAL ZONE (OUTER-WALL TO OUTER-WALL) WAS 24.5 MM. THE % CHANGE IN SEAL ZONE DIAMETER THROUGHOUT THE LENGTH OF THE SEAL ZONE WAS 9.26 THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 69 MM. THE LENGTH OF THE AORTA FROM THE MOST DISTAL ASPECT OF THE CELIAC ARTERY TO THE MOST DISTAL ASPECT OF THE SMA WAS 15.9 MM. THE LENGTH OF THE AORTA FROM THE MOST DISTAL ASPECT OF THE CELIAC ARTERY TO THE MOST DISTAL ASPECT OF THE RIGHT RENAL ARTERY WAS 21.9 MM. THE LENGTH OF THE AORTA FROM THE MOST DISTAL ASPECT OF THE CELIAC ARTERY TO THE MOST DISTAL ASPECT OF THE LEFT RENAL ARTERY WAS 26.9 MM. THE LENGTH OF THE AORTA FROM THE MOST DISTAL ASPECT OF THE CELIAC ARTERY TO THE AORTIC BIFURCATION WAS 157.2 MM. THE LENGTH OF THE AORTA FROM THE MOST DISTAL ASPECT OF THE LOWEST PATENT RENAL ARTERY TO THE AORTIC BIFURCATION WAS 157.2 MM. THE DIAMETER OF THE AORTA 20 MM PROXIMAL TO THE MOST ASPECT OF THE CELIAC ARTERY (OUTER WALL TO OUTER WALL) WAS 27.0 MM. THE DIAMETER OF THE AORTA AT THE MOST DISTAL ASPECT OF THE CELIAC ARTERY (OUTER WALL TO OUTER WALL) WAS 27.5 MM. THE DIAMETER OF THE AORTA AT THE MOST DISTAL ASPECT OF THE SMA (OUTER WALL TO OUTER WALL) WAS 26.0 MM. THE DIAMETER OF THE AORTA AT THE MOST DISTAL ASPECT OF THE RIGHT RENAL ARTERY (OUTER WALL TO OUTER WALL) WAS 24.5 MM. THE DIAMETER OF THE AORTA AT THE MOST DISTAL ASPECT OF THE LEFT RENAL ARTERY (OUTER WALL TO OUTER WALL) WAS 26.0 MM. THE DIAMETER OF THE AORTA 15 MM DISTAL TO THE MOST DISTAL ASPECT OF LOWEST PATENT RENAL ARTERY (OUTER WALL TO OUTER WALL) WAS 42.0 MM. THE DIAMETER OF THE AORTA AT THE LOCATION OF MAXIMUM ANEURYSM DIAMETER (OUTER WALL TO OUTER WALL) WAS 53.6 MM. THE DIAMETER OF THE AORTA AT THE AORTIC BIFURCATION (INNER WALL TO INNER WALL) WAS 16.5 MM. VISCERAL VESSEL ORIENTATION: THE ANGLE OF THE CELIAC WITH RESPECT TO THE AORTA WAS 50 DEGREES. THE CIRCUMFERENTIAL LOCATION OF THE SMA RELATIVE TO THE CELIAC ARTERY (WITH CELIAC AT 0 DEGREES) WAS 1 DEGREE. THE ANGLE OF THE SMA WITH RESPECT TO THE AORTA WAS 63 DEGREES. THE CIRCUMFERENTIAL LOCATION OF THE RIGHT RENAL ARTERY RELATIVE TO THE CELIAC ARTERY (WITH CELIAC AT 0 DEGREES) WAS 271 DEGREES. THE ANGLE OF THE RIGHT RENAL ARTERY (WITH RESPECT TO AORTA 0-180 DEGREES) WAS 56 DEGREES. THE CIRCUMFERENTIAL LOCATION OF THE LEFT RENAL ARTERY RELATIVE TO THE CELIAC ARTERY (WITH CELIAC AT 0 DEGREES, 0-360) WAS 62 DEGREES. THE ANGLE OF THE LEFT RENAL ARTERY (WITH RESPECT TO AORTA 0-180 DEGREES) WAS 83 DEGREES. THE ANGULATION BETWEEN THE INFRA-RENAL AORTA AND THE ANEURYSM CENTERLINE WAS 35.9 DEGREES. THE MAXIMUM ANGULATION ABOVE THE INFRA RENAL AORTA (WITHIN REGION OF ZFEN+ AND DELIVERY SYSTEM WAS 7.6 DEGREES. THE DISTAL SEAL ZONE WAS NOT IN THE ABDOMINAL AORTA. THE DIAMETER OF THE CELIAC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 7.0 MM. THE LENGTH FROM THE CELIAC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 22.4 MM. THE DIAMETER OF THE SUPERIOR MESENTERIC ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 6.5 MM. THE LENGTH FROM THE SUPERIOR MESENTERIC ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 45.2 MM. THE DIAMETER OF THE RIGHT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 4.5 MM. THE LENGTH FROM THE RIGHT RENAL ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 55.8 MM. THE DIAMETER OF THE LEFT RENAL ARTERY AT THE LOCATION OF INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) WAS 4.0 MM. THE LENGTH FROM THE LEFT RENAL ARTERY OSTIUM TO THE FIRST MAJOR BIFURCATION WAS 33.2 MM. THERE WAS NO STENOSIS OF THE CELIAC ARTERY, SMA, RIGHT RENAL ARTERY, OR LEFT RENAL ARTERY. THERE WERE NO ACCESSORY RENAL ARTERIES. NO RIGHT OR LEFT RENAL ARTERY INFARCT WAS PRESENT. THE RIGHT COMMON ILIAC ARTERY LENGTH FROM THE AORTIC BIFURCATION TO THE ILIAC BIFURCATION WAS 66.3 MM. THE DIAMETER OF THE VESSEL AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) MEASURED 13.5 MM. THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY AT THE LOCATION OF MAXIMUM DIAMETER (OUTER WALL TO OUTER WALL) MEASURED 15.0 MM. THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY AT THE LOCATION OF MINIMUM DIAMETER (INNER WALL TO INNER WALL) MEASURED 10.0 MM. THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY AT THE LOCATION OF MINIMUM DIAMETER (INNER WALL TO INNER WALL) MEASURED 6.5 MM. THE LEFT COMMON ILIAC ARTERY LENGTH FROM THE AORTIC BIFURCATION TO THE ILIAC BIFURCATION WAS 63.1 MM. THE DIAMETER OF THE VESSEL AT THE LOCATION OF THE INTENDED DISTAL LANDING ZONE (OUTER WALL TO OUTER WALL) MEASURED 11.5 MM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY AT THE LOCATION OF MAXIMUM DIAMETER (OUTER WALL TO OUTER WALL) MEASURED 19.5 MM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY AT THE LOCATION OF MINIMUM DIAMETER (INNER WALL TO INNER WALL) MEASURED 11.5 MM. THE DIAMETER OF THE LEFT EXTERNAL ILIAC ARTERY AT THE LOCATION OF MINIMUM DIAMETER (INNER WALL TO INNER WALL) MEASURED 8.5 MM ILIAC MORPHOLOGY: NO OCCLUSIVE DISEASE WAS PRESENT IN THE COMMON ILIAC ARTERIES. THE RIGHT COMMON ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE RIGHT EXTERNAL ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE RIGHT EXTERNAL ILIAC ARTERY OCCLUSIVE DISEASE WAS DESCRIBED AS MILD. THE RIGHT FEMORAL ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE RIGHT FEMORAL ARTERY WAS FREE OF OCCLUSIVE DISEASE. THERE WAS NO TORTUOSITY OF THE RIGHT ILIAC ARTERY. THE LEFT COMMON ILIAC ARTERY CALCIFICATION WAS DESCRIBED AS MILD. NO CALCIFICATION OR OCCLUSIVE DISEASE WAS PRESENT IN THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT FEMORAL ARTERY CALCIFICATION WAS DESCRIBED AS MILD. THE LEFT FEMORAL ARTERY WAS FREE OF OCCLUSIVE DISEASE. THERE WAS MILD TORTUOSITY OF THE LEFT ILIAC ARTERY. NO OTHER VESSELS OTHER THAN THE CELIAC, SMA, RIGHT RENAL OR LEFT RENAL WERE TARGETED WITH A FENESTRATION OR SCALLOP. THE RIGHT EXTERNAL ILIAC ARTERY APPEARS TO HAVE FOCAL DISSECTION. AN OPERATIVE REPORT FROM THE SITE WAS PROVIDED AND DE-IDENTIFIED. PHYSICAL EXAM: BLOOD PRESSURE 125/76, PULSE: 70, TEMPERATURE: 97.7 DEGREES FAHRENHEIT CHIEF COMPLAINT: AAA, SURGICAL EVALUATION. CAUCASIAN MALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, GERO, ATRIAL FIBRILLATION ON ELIQUIS, CAD STATUS POST PCI 2002 POST ML WHO HAS A PARARENAL AAA. TODAY, THE PATIENT REPORTS NO CHANGES IN HIS HISTORY. THE PATIENT HAS BEEN AMBULATING WITHOUT DIFFICULTY. APPETITE, BOWEL MOVEMENTS, AND URINATION HAVE BEEN UNREMARKABLE. HE DENIES FEVERS OR CHILLS. HE IS TAKING ELIQUIS WITHOUT ANY ISSUES. IMAGING AND OTHER STUDIES: I PERSONALLY REVIEWED THE PATIENT'S CTA CHEST/ABDOMEN/PELVIS WHICH SHOWED 4.4CM ASCENDING, 2.5CM SUPRA CELIAC, 5.5CM PARARENAL AORTA. ECHOCARDIOGRAM (B)(6) 2023. EF 61 %, STAGE 1 DIASTOLIC DYSFUNCTION, MILD CONCENTRIC LVH, DILATED RA/RV, MILD MITRAL REGURGITATION, TRIVIAL TO MILD TRICUSPID REGURGITATION, MILD AORTIC REGURGITATION, MILDLY DILATED AORTIC ROOT (4.2 CM), ASCENDING AORTA (4.5 CM), DESCENDING AORTA (4.4 CM) STRESS TEST (B)(6) 2023. NO EVIDENCE OF ISCHEMIA BY ECG CRITERIA, NO SIGNIFICANT DYSRHYTHMIA CAROTID DUPLEX (B)(6)2024. THERE IS MINIMAL PLAQUE FORMATION WITHIN BOTH CAROTID BULBS ALTHOUGH WITHOUT STENOSIS IDENTIFIED (<<50%) ON EITHER SIDE. CRA (B)(6)2024 - HIGH RISK DUE TO AGE AND CO-MORBIDITIES. CONSTITUTIONAL: ALERT, ORIENTED, NO ACUTE DISTRESS CHEST: CLEAR TO AUSCULTATION. CARDIAC: REGULAR RATE AND RHYTHM ABDOMEN: SOFT, NONTENDER, AND NONDISTENDED VASCULAR: PALPABLE PT/DP BILATERALLY SKIN: NO ERYTHEMA, SWELLING OR TENDERNESS NEUROLOGIC: ALERT, ORIENTED, NORMAL SPEECH, NO FOCAL FINDINGS OR MOVEMENT DISORDER NOTED ASSESSMENT/PLAN: ----A 85 Y.O. CAUCASIAN MALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, GERO, ATRIAL FIBRILLATION ON ELIQUIS, CAD STATUS POST PCI 2002 POST ML WHO HAS A 5.5CM PARARENAL AAA. DISCUSSED HOW MEETS SIZE CRITERIA FOR INTERVENTION TO REDUCE RISK OF AORTIC RELATED MORTALITY. WOULD RECOMMEND FENESTRATED ENDOVASCULAR REPAIR. HE DOES NOT HAVE AN INFRARENAL DEVICE OPTION AND THEREFORE WILL INVESTIGATE ABILITY TO GET ENROLLED IN ZFEN+ TRIAL. HIS CT HAS BEEN SUBMITTED TODAY. HE HAS BEEN CLEARED FROM CARDIOLOGY STANDPOINT. DISCUSSED RISKS OF SURGERY INCLUDING FAILURE TO THRIVE, RENAL/BOWEL/LEG ISCHEMIA AMONG OTHER ISSUES. DISCUSSED TYPICAL RECOVERY PERIOD. HE NEEDS TO MEET WITH SPINE SURGEON AS WELL AS HE IS QUITE LIMITED FROM A BACK STANDPOINT. NEEDS TO STOP ELIQUIS 48 HOURS. DIAGNOSIS: AAA (ABDOMINAL AORTIC ANEURYSM) WITHOUT RUPTURE. PREOPERATIVE DIAGNOSIS: 5.5CM THORACOABDOMINAL (EXTENT IV) AORTIC ANEURYSM POSTOPERATIVE DIAGNOSIS: 5.5CM THORACOABDOMINAL (EXTENT IV) AORTIC ANEURYSM PROCEDURE: 1. PERCUTANEOUS 4-VESSEL FENESTRATED ENDOVASCULAR REPAIR OF THORACOABDOMINAL (EXTENT IV) AORTA (USING COOK ZFEN+ CLINICAL TRIAL DEVICE 30-163, BIFURCATED BODY 2-24-81, L ILIAC 13-56 AND 16-7 4, R ILIAC 16-90) 2. STENTING OF THE CELIAC ARTERY (9X27MM COMPETITOR'S STENT FLARED TO 10MM AT ORIGIN) 3. STENTING OF THE SUPERIOR MESENTERIC ARTERY (9X37MM COMPETITOR'S STENT FLARED TO 10MM AT ORIGIN) 4. STENTING OF THE RIGHT RENAL ARTERY (6X28MM COMPETITOR'S STENT FLARED TO 9MM AT ORIGIN) 5. STENTING OF THE LEFT RENAL ARTERY (6X28MM COMPETITOR'S STENT FLARED TO 9MM AT ORIGIN) 6. OPEN EXPOSURE OF LEFT COMMON FEMORAL ARTERY FOR DELIVERY OF ENDOPROSTHESIS TWO SURGEONS WERE REQUIRED FOR THIS OPERATION DUE TO ITS COMPLEXITY AND LACK OF QUALIFIED RESIDENT. ANESTHESIA: GENERAL INDICATIONS: CAUCASIAN MALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, GERD, ATRIAL FIBRILLATION ON ELIQUIS, CAD STATUS POST PCI 2002 POST ML WHO HAS A 5.5CM EXTENT IV TAAA. GIVEN THESE FINDINGS, ENDOVASCULAR REPAIR WAS RECOMMENDED TO THE PATIENT. THE RISKS AND BENEFITS OF SURGERY INCLUDING ENDOLEAK, NEED FOR REINTERVENTION, AND SPINAL CORD ISCHEMIA AMONG OTHERS WERE DISCUSSED WITH THE PATIENT AND FAMILY. THE PATIENT AND FAMILY UNDERSTOOD THE RISKS AND BENEFITS OF SURGERY AND ALL QUESTIONS WERE ANSWERED. HE WAS ENROLLED IN THE ZFEN+ CLINICAL TRIAL FOR A 4-VESSEL FENESTRATED DEVICE TO OBTAIN APPROPRIATE PROXIMAL SEAL. OPERATIVE NOTE: AFTER PROPER POSITIONING OF THE PATIENT SUPINE AND OBTAINING THE NECESSARY VASCULAR ACCESS, ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION AND APPROPRIATE ANTIBIOTICS WERE GIVEN. PRIOR TO BEGINNING, ANOTHER SURGICAL TIMEOUT WAS PERFORMED. UNDER ULTRASOUND GUIDANCE, A MICROPUNCTURE NEEDLE AND WIRE WERE INTRODUCED INTO THE RIGHT COMMON FEMORAL ARTERY. FLUOROSCOPY CONFIRMED WIRE WITHIN THE AORTOILIAC SYSTEM. THE MICROPUNCTURE SHEATH WAS INSERTED FOLLOWED BY A 0.035 COMPETITOR'S GUIDE WIRE. THE SOFT TISSUE AND FASCIA WERE SPREAD WITH A CLAMP. TWO SUTURE MEDIATED CLOSURE DEVICES WERE SEQUENTIALLY INSERTED AND THEIR SUTURE SECURED WITH CLAMPS. AN 8-F SHEATH WAS THEN INSERTED. ATTENTION WAS THEN TURNED TO THE LEFT GROIN WHERE THE MICROPUNCTURE SYSTEM WAS USED WITH ULTRASOUND GUIDANCE AND THEN THE SOFT TISSUE WAS SPREAD, AND TWO COMPETITOR'S WIRE GUIDES WERE INSERTED FOLLOWED BY AN 8F SHEATH. THE PATIENT WAS NOW SYSTEMICALLY HEPARINIZED FOR AN ACT>250 SECONDS. NEXT, WE EXCHANGED FOR A LUNDERQUIST WIRE ON THE LEFT GROIN AND POSITIONED IT IN THE DESCENDING THORACIC AORTA AND SERIALLY DILATED THE VESSEL TO 14F AND THEN INSERTED AN 14F COMPETITOR'S SHEATH. THROUGH IT, WE PLACED A PIGTAIL CATHETER. WE THEN POSITIONED A LUNDERQUIST WIRE ON THE RIGHT GROIN INTO THE DESCENDING THORACIC AORTA AND SERIALLY DILATED THE ARTERIOTOMY AND THEN INSERTED THE COOK 4-VESSEL FENESTRATED 30X163MM DEVICE. WE THEN PERFORMED ANGIOGRAPHY TO REFINE OUR FUSION MARKS AND ADJUSTED THE POSITION OF THE ENDOGRAFT AS NECESSARY. WE THEN UNSHEATHED THE DEVICE LINING UP THE FENESTRATIONS WITH THE FUSION MARKS. ONCE THE DEVICE WAS FULLY UNSHEATHED, WE INSERTED A WIRE ON THE LEFT SIDE AND ENSURED THAT THE WIRE HAD SELECTED THE DISTAL OPENING OF THE GATE AS OPPOSED TO BEING OUTSIDE THE GRAFT. WE THEN ADVANCED OUR 14F COMPETITOR'S SHEATH INTO THE GATE OF THE ENDOGRAFT AND THEN INSERTED A 7F COMPETITOR'S SHEATH AND USING A COMPETITOR'S CATHETER AND A WIRE GUIDE, WE SELECTED THE SUPERIOR MESENTERIC FENESTRATION AND ARTERY. ADVANCED THE COMPETITOR'S CATHETER AND ANGIOGRAPHY CONFIRMED OUR LOCATION AND THEN WE EXCHANGED FOR A ROSEN WIRE. WE THEN RE STUCK THE 14F COMPETITOR'S SHEATH WITH A WIRE GUIDE AND INSERTED A 7F COMPETITOR'S SHEATH OVER IT. USING A COMPETITOR'S CATHETER AND GUIDE WIRE, WE SELECTED THE LEFT RENAL FENESTRATION AND ARTERY. ANGIOGRAPHY CONFIRMED LOCATION WE THEN EXCHANGED FOR A ROSEN WIRE. WE ONCE AGAIN RE STUCK THE 14F COMPETITOR'S SHEATH AND USING THE 7F COMPETITOR'S SHEATH SELECTED THE RIGHT RENAL FENESTRATION AND ARTERY. THE CATHETER WAS ADVANCED OUT THE RIGHT RENAL ARTERY AND ANGIOGRAPHY CONFIRMED POSITION. WE EXCHANGED FOR A ROSEN WIRE. FINALLY, WE RESTUCK THE 14FCOMPETITOR'S SHEATH ONCE AGAIN AND USING THE 7F COMPETITOR'S SHEATH AND A WIRE GUIDE WE SELECTED THE CELIAC FENESTRATION AND ARTERY. THE CATHETER WAS ADVANCED, AND ANGIOGRAPHY CONFIRMED POSITION. WE EXCHANGED FOR A ROSEN WIRE AND ADVANCED THE 7F COMPETITOR'S SHEATH OUT INTO THE VESSEL AND INSERTED A COMPETITOR'S 9X27MM STENT. NOW WITH ALL FENESTRATIONS/VESSELS CANNULATED, WE DEPLOYED THE FENESTRATED ENDOGRAFT TOP CAP RELEASING THE BARE STENT. THE DELIVERY SYSTEM WAS THEN REMOVED AND THE ARTERIOTOMY EXCHANGED FOR A 18F COMPETITORS' SHEATH THROUGH WHICH A CODA BALLOON WAS INSERTED. WE BALLOONED THE MAIN BODY OF THE ENDOGRAFT. WE THEN TURNED ATTENTION TO DEPLOYMENT OF OUR BRIDGING STENTS. WE NOW DEPLOYED THE COMPETITOR'S 9X27MM STENT IN THE CELIAC ARTERY ENSURING THAT AT LEAST 4MM OF IT WERE HANGING INTO THE AORTA. WE THEN FLARED THE ORIGIN OF THE STENT WITH A 1 0X20MM BALLOON. COMPLETION ANGIOGRAPHY SHOWED NO ENDOLEAK AND GOOD FILLING OF THE CELIAC ARTERY. THE 7F SHEATH WAS WITHDRAWN. A 7F SHEATH WAS NOW SENT OVER THE WIRE OUT THE SUPERIOR MESENTERIC ARTERY AND WE NOW ADVANCED A COMPETITOR'S 9X37MM STENT INTO THE SUPERIOR MESENTERIC ARTERY AND DEPLOYED IT HANGING ABOUT 4MM INTO THE MAIN ENDOGRAFT AND THEN SENT A 1 0X20MM BALLOON TO FLARE THE ORIGIN. COMPLETION ANGIOGRAPHY WAS EXCELLENT. THE SHEATH WAS WITHDRAWN, AND WE NOW USED A 7F SHEATH OVER THE RIGHT RENAL WIRE AND ADVANCED IT INTO THE VESSEL AND THEN SENT A COMPETITOR'S 6X28MM STENT. IT WAS DEPLOYED WITH ~4MM HANGING INTO THE AORTA AND THEN IT WAS FLARED AT THE ORIGIN WITH A 9X20MM BALLOON. THE SHEATH WAS REMOVED AFTER NORMAL COMPLETION IMAGING. WE NOW SENT 7F SHEATH OUT THE LEFT RENAL ARTERY WIRE AND INSERTED AND DEPLOYED A COMPETITOR'S 6X28MM WITH ~4 MM INTO THE AORTA AND THAT SEGMENT WAS FLARED WITH A 9X20MM BALLOON. COMPLETION IMAGING WAS EXCELLENT. WE NOW INSERTED THE UNIVERSAL MAIN BODY BIFURCATED DEVICE AND WITH APPROPRIATE OVERLAP IT WAS DEPLOYED. WE CANNULATED THE GATE FROM THE LEFT SIDE, PERFORMED RETROGRADE ANGIOGRAPHY TO MARK THE LEFT HYPOGASTRIC ARTERY ORIGIN. BASED ON MARKER PIGTAIL, WE SELECTED, INSERTED, AND DEPLOYED A COOK 13-56 LIMB AS AN EXTENSION AND THEN ADDED A COOK 16-74MM ILIAC LIMB LANDING IT WITH ADEQUATE OVERLAP WITH THE PRIOR LIMB AND LANDING DISTALLY JUST ABOVE THE HYPOGASTRIC ARTERY. THE DELIVERY SYSTEM WAS REMOVED, AND A CODA BALLOON WAS USED TO TREAT ALL OVERLAP AND OUR DISTAL SEAL ZONE. WE THEN FINISHED DEPLOYING THE IPSILATERAL SIDE OF UNIVERSAL BODY AND RETROGRADE IMAGING DONE FOR THE RIGHT INTERNAL ILIAC AND THEN INSERTED AND DEPLOYED A 16-90MM COOK ILIAC LIMB LANDING JUST ABOVE THE INTERNAL ILIAC. ALL OVERLAP WAS BALLOONED AND DISTAL SEAL. WITH ALL COMPLETED, WE NOW INSERTED A PIGTAIL CATHETER FOR COMPLETION IMAGING WHICH SHOWED EXCELLENT FLOW INTO THE VISCERALS AND RENALS WITH NO TYPE I, II OR 111 ENDOLEAK. WE WERE PLEASED WITH THE RESULT. THE SUTURE MEDIATED CLOSURE DEVICES WERE USED WITH SUCCESS ON THE RIGHT FEMORAL ARTERY BUT ON THE LEFT THEY FAILED. I THEREFORE MADE AN OBLIQUE INCISION, DIVIDED THE SOFT TISSUE AND CONTROLLED THE COMMON FEMORAL ARTERY ABOVE AND BELOW THE ARTERIOTOMY. THE VESSEL WAS CLAMPED AND THE SHEATH REMOVED AND THE ARTERIOTOMY WAS CLOSED WITH 5-0 SUTURES IN INTERRUPTED MANNER. THERE WAS PALPABLE PEDAL PULSES NOW. PROTAMINE WAS GIVEN. WOUND WAS HEMOSTATIC AND IRRIGATED AND THEN CLOSED IN LAYERS WITH 2-0 AND 3-0 SUTURES FOLLOWED BY 4-0 SUTURE ON THE SKIN. THE PATIENT WAS AWAKENED AND EXTUBATED AND NOTED TO MOVE BOTH LOWER EXTREMITIES STRONGLY. HE WAS TAKEN UP TO THE ICU IN STABLE CONDITION. ALL COUNTS WERE CORRECT, AND I WAS PRESENT AND SCRUBBED FOR THE ENTIRE DURATION OF THE OPERATION. CYDAR USED: YES COMPLETION CONE BEAN CT: YES CONTRAST: 75CC FLUORO TIME: 33.2MIN DOSE AREA PRODUCT: 410.189GY-CM"2 CUMULATIVE AIR KARMA: 2172.12MGY ESTIMATED BLOOD LOSS: 250CC PRBC: 1 UNIT BRIEF OPERATIVE REPORT: GENDER: MALE DATE OF PROCEDURE: (B)(6) 2024 PREOPERATIVE DIAGNOSIS: AAA (ABDOMINAL AORTIC ANEURYSM) WITHOUT RUPTURE (HC CODE) [171.40] POSTOPERATIVE DIAGNOSIS: 5.3CM PARARENAL AAA PROCEDURE(S): FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR (USING COOK ZFEN+ CLINICAL TRIAL DEVICE), LEFT GROIN CUTDOWN, COMMON FEMORAL ARTERY PRIMARY REPAIR ANESTHESIA: GENERAL EBL: 250ML IVF: 1000ML CRYSTALLOID, 250CC ALBUMIN, 1 U PRBC DRAINS: FOLEY WOUND CLASS: CLEAN -ATRAUMATIC WOUND; NO ENTRY INTO RESPIRATORY/GI/GU/BILIARY TRACTS. DESCRIPTION OF FINDINGS: COMPLETION ANGIOGRAPHY WITHOUT ENDOLEAK, LEFT GROIN WITH SUTURE MEDIATED CLOSURE DEVICE FAILURE REQUIRING CUTDOWN AND PRIMARY REPAIR PATIENT CONDITION: ICU -EXTUBATED AND STABLE. AN OPERATIVE SUMMARY WAS PROVIDED BY THE SITE. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6)2024. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 07:23 ADMINISTRATION OF ANESTHESIA: 07:23 TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 08:22 INITIAL CATHETER INSERTED: 08:36 FINAL CATHETER REMOVED 10:10 ALL INCISION CLOSURES COMPLETED: 11:39 TIME PATIENT LEAVES ROOM: 12:03 ESTIMATED BLOOD LOSS: 250 CC THE PATIENT RECEIVED 325 CC OF PACKED RED BLOOD CELLS. TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE: 75 ML CONTRAST CONCENTRATION: 350 MG/ML TOTAL FLUOROSCOPY TIME (FROM INCISION TO REMOVAL): 33 MINUTES RADIATION DOSE (TOTAL DURING PROCEDURE): 2172 MGY. THE RIGHT FEMORAL ARTERY WAS USED FOR PERCUTANEOUS ACCESS. THE LEFT FEMORAL ARTERY WAS CUT DOWN FOR CONTRALATERAL ACCESS. SUCCESSFUL DEPLOYMENT IN ALL INTENDED LOCATIONS FOR ALL DEVICES WAS ACHIEVED. ALL DELIVERY SYSTEM DEVICES WERE ABLE TO BE WITHDRAWN SUCCESSFULLY. NO UNANTICIPATED CORRECTIVE INTERVENTIONS WERE REQUIRED DURING THE PROCEDURE. NO BRIDGING STENTS WERE UNABLE TO BE DELIVERED OR DEPLOYED DUE TO BEING STRIPPED OFF THE BALLOON. THE FOLLOWING COOK DEVICES WERE IMPLANTED DURING THE PROCEDURE: COOK ZENITH FENESTRATED + DEVICE, (RPN: ZFEN+30-163-CI) THERE WAS NO DIFFICULTY FLUSHING THE INTRODUCER SYSTEM AND REMOVING THE RELEASE WIRES. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE DEVICE FROM THE START TO THE END OF THE IMPLANT. THERE WAS NO DIFFICULTY CANNULATING THE FENESTRATIONS OR RETRACTING THE SHEATH. COOK UNIVERSAL DISTAL BODY (RPN: UNIBODY2-24-81-CI) WAS PLACED USING CONTRALATERAL ACCESS THE AMOUNT OF OVERLAP WITH THE PRECEDING COMPONENT WAS 2.5 STENTS. THERE WERE NO DIFFICULTIES IN REMOVING THE RELEASE WIRES OR RETRACTING THE SHEATH. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE DEVICE FROM THE START TO THE END OF THE IMPLANT. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT) WAS PLACED IN THE RIGHT COMMON ILIAC ARTERY. THE AMOUNT OF OVERLAP WITH THE PRECEDING COMPONENT WAS 2.5 STENTS. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT) WAS PLACED IN THE LEFT COMMON ILIAC ARTERY. THE AMOUNT OF OVERLAP WITH THE PRECEDING COMPONENT WAS 1.5 STENTS. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT) WAS PLACED IN THE LEFT COMMON ILIAC ARTERY. THE AMOUNT OF OVERLAP WITH THE PRECEDING COMPONENT WAS 2 STENTS. COMPETITOR¿S BRIDGING STENTS: FROM THE CONTRALATERAL ACCESS, A COMPETITOR¿S STENT WAS PLACED IN THE CELIAC ARTERY. 10 ATMOSPHERES (ATM) OF INFLATION PRESSURE WERE USED TO EXPAND THE BRIDGING STENT. THE STENT WAS FLARED. A COMPETITOR¿S 10 X 2 MM BALLOON WAS INFLATED TO 12 ATM FOR FLARING. NO ISSUES WERE ENCOUNTERED DURING FLARING. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. FROM THE CONTRALATERAL ACCESS, A COMPETITOR¿S STENT WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY (SMA). 8 ATMOSPHERES (ATM) OF INFLATION PRESSURE WERE USED TO EXPAND THE BRIDGING STENT. THE STENT WAS FLARED. A COMPETITOR¿S 10 X 2MM BALLOON WAS INFLATED TO 12 ATM FOR FLARING. NO ISSUES WERE ENCOUNTERED DURING FLARING. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. FROM THE CONTRALATERAL ACCESS, A COMPETITOR¿S STENT WAS PLACED IN THE RIGHT RENAL ARTERY. 9 ATMOSPHERES (ATM) OF INFLATION PRESSURE WERE USED TO EXPAND THE BRIDGING STENT. THE STENT WAS FLARED. A COMPETITOR¿S 9 X 2 MM BALLOON WAS INFLATED TO 12 ATM FOR FLARING. NO ISSUES WERE ENCOUNTERED DURING FLARING. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. FROM THE CONTRALATERAL ACCESS, A COMPETITOR¿S STENT WAS PLACED IN THE LEFT RENAL ARTERY. 9 ATMOSPHERES (ATM) OF INFLATION PRESSURE WERE USED TO EXPAND THE BRIDGING STENT. THE STENT WAS FLARED. A COMPETITOR¿S 9 X 2 MM BALLOON WAS INFLATED TO 12 ATM FOR FLARING. NO ISSUES WERE ENCOUNTERED DURING FLARING. THE CLINICIAN WAS ABLE TO ADEQUATELY VISUALIZE THE BRIDGING STENT FROM THE START TO THE END OF THE IMPLANT. OTHER COOK DEVICES USED IN THE PROCEDURE INCLUDED: AND THE FOLLOWING COOK ANCILLARY DEVICES WERE USED DURING THE PROCEDURE: ENDOVASCULAR DILATOR SET (RPN: JCDS-14-EDS-HC) ENDOVASCULAR DILATOR SET (RPN: JCDS-1618-EDS-HC) CODA LP BALLOON CATHETER (RPN: CODA-2-9.0-35-120-32) MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET (RPN: MPIS-501-10.0-SC-NT-SST) LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE (RPN: TSCMG-35-260-7-LES) LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE (RPN: TSCMG-35-260-7-LES) THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT ON (B)(6)2024 AND WAS DISCHARGED FROM THE ICU ON (B)(6)2024. RESUMPTION OF ORAL FLUID INTAKE OCCURRED ON (B)(6)2024. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2024. PROCEDURAL IMAGING IN THE FORM OF AN ANGIOGRAPHY SCAN WAS COMPLETED ON (B)(6)2024. ALL OF THE DEVICES WERE PATENT AT THE END OF THE PROCEDURE. THERE WAS NO ENDOLEAK PRESENT. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. A POST PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED IN PERSON ON (B)(6)2025, 35 DAYS POST PROCEDURE. THE PATIENT WAS TAKING ANTITHROMBOTIC MEDICATIONS. SINCE THE PROCEDURE, THE PATIENT HAS NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR BEEN HOSPITALIZED FOR ANY REASON. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6)2025, 35 DAYS AFTER THE PROCEDURE. THE ENDOGRAFT DEVICES WERE ALL PATENT. THERE WAS NO STENOSIS IN ANY VESSEL GREATER THAN 50% IDENTIFIED IN ANY TREATED VESSEL. VISCERAL VESSEL PATENCY: THE CELIAC ARTERY NATIVE VESSEL WAS PATENT AND WAS PATENT WITHIN THE STENT. THE SMA NATIVE VESSEL WAS PATENT AND WAS PATENT WITHIN THE STENT. THE RIGHT RENAL ARTERY NATIVE VESSEL WAS PATENT AND WAS PATENT WITHIN THE STENT. THE LEFT RENAL ARTERY NATIVE VESSEL WAS PATENT AND WAS PATENT WITHIN THE STENT. THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 54 MM. THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 14 MM. THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY AT LOCATION OF MAXIMUM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 18 MM. NO ENDOLEAKS WERE PRESENT. NO SEPARATION OF COMPONENTS HAD OCCURRED. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THERE WAS NO EVIDENCE OF THROMBUS WITHIN THE DEVICES. A REVIEW OF THE POST OPERATIVE CT WITH CONTRAST SCAN WAS COMPLETED ON (B)(6)2025 BY AN INDEPENDENT LABORATORY. ALL ENDOGRAFTS WERE PATENT. NO ENDOLEAKS WERE PRESENT. NO SEPARATION OF COMPONENTS OCCURRED. THERE WAS NO EVIDENCE OF DEVICE INTEGRITY ISSUES. THE RIGHT EXTERNAL ILIAC FOCAL DISSECTION WAS UNCHANGED COMPARED TO THE PRE-OPERATIVE CT SCAN. HOWEVER, THERE WAS A NEW FOCAL DISSECTION AT THE RIGHT COMMON FEMORAL ARTERY (CFA).
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 |
|---|---|---|---|---|---|---|---|
| 465642 | ENDOVASCULAR DILATOR SET | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | COOK INC | G52834 | 16270991 | 00827002528345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Life Threatening | BENTLEY BGUS0628_2, LOT# B00005| BENTLEY BGUS0628_2, LOT# B00005| BENTLEY BGUS0927_2, LOT# B00021| BENTLEY BGUS0937_2, LOT# B00028| COOK RPN: MPIS-501-10.0-SC-NT-SST, LOT 16284690| COOK RPN: CODA-2-9.0-35-120-3 LOT 16256161| COOK RPN: TSCMG-35-260-7-LES, LOT# E46603934| COOK RPN: UNIBODY2-24-81-CI, LOT A1164837| COOK RPN: ZFEN+30-163-CI, LOT AC1171632| COOK RPN: ZSLE-13-56-ZT, LOT 16192678| COOK RPN: ZSLE-16-74-ZT, LOT 16343591| COOK RPN: ZSLE-16-90-ZT, LOT 16324298| COOK TSCMG-35-260-7-LES, LOT E4589342 |