ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2024-00382
- Event Type
- Malfunction
- Date Received
- March 20, 2024
- Date of Event
- February 23, 2024
- Report Date
- June 14, 2024
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552415
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: UNKNOWN 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 NOTIFIED THAT A PATIENT HAD A TYPE 1B ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING THE PROCEDURE AND PERSISTENT IN THE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN. NO FOLLOW UP PROCEDURE HAS BEEN COMPLETED TO ADDRESS THE TYPE 1B ENDOLEAK. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. 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. HOWEVER, IMAGING WAS PROVIDED. THE IMAGING WAS REVIEWED BY AN EXPERT IMAGE REVIEWER AND CONFIRMED A SMALL TYPE 1B ENDOLEAK FROM THE RIGHT ILIAC LEG GRAFT SHOWN ON THE OPERATIVE ANGIOGRAMS. THE SMALL TYPE 1B ENDOLEAK IS PRESENT ON THE CT SCAN TAKEN 6 DAYS POST-PROCEDURE. THE REVIEWER INDICATED THAT THE ENDOLEAK WAS DUE MAINLY TO THE IRREGULARITY OF THE LANDING ZONE IN THE RIGHT COMMON ILIAC ARTERY. HOWEVER, IT WAS NOTED THAT THE ENDOLEAK MAY SETTLE SPONTANEOUSLY OVER TIME. 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-CONFORMANCE'S RELEVANT TO THE FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. 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 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. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP 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 SHEATHS. 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. 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 ENHANCES FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED, INCLUDING: 1) ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (SEPARATION BETWEEN COMPONENTS OR STENT FRACTURE) AND 2) CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. 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 (TABLE 10.5.1). APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING AND COMPRESSION. 4.5 IMPLANT PROCEDURE APPROPRIATE PROCEDURAL IMAGING IS REQUIRED TO SUCCESSFULLY POSITION THE ZENITH SPIRAL-Z AAA ILIAC LEG AND ASSURE ACCURATE APPOSITION TO THE VESSEL WALL. 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, BLEEDING, HEMATOMA OR COAGULOPATHY, 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 7.1 INDIVIDUALIZATION OF TREATMENT ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: RISKS AND DIFFERENCES BETWEEN ENDOVASCULAR REPAIR AND SURGICAL REPAIR CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY) PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR THE RISK OF ANEURYSM RUPTURE COMPARED TO THE RISK OF TREATMENT WITH THE ZENITH SPIRAL-Z AAA ILIAC LEG PATIENT¿S ABILITY TO TOLERATE GENERAL, REGIONAL OR LOCAL ANESTHESIA ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT. THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 8 PATIENT COUNSELING INFORMATION PHYSICIAN 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. 11 DIRECTIONS FOR USE PRE-IMPLANT DETERMINANTS VERIFY FROM PRE-IMPLANT PLANNING THAT THE CORRECT DEVICES HAS BEEN SELECTED. DETERMINANTS INCLUDE: 1. FEMORAL ARTERY SELECTION FOR INTRODUCTION OF THE DELIVERY SYSTEM (I.E., DEFINE RESPECTIVE CONTRALATERAL AND IPSILATERAL ILIAC ARTERIES) 2. ANGULATION OF AORTIC NECK, ANEURYSM AND ILIAC ARTERIES 3. DIAMETERS OF INFRARENAL AORTIC NECK AND DISTAL ILIAC ARTERIES. 4. LENGTH FROM THE AORTIC BIFURCATION OF A PREVIOUSLY PLACED MAIN BODY OR RENU FORM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS TO THE INTERNAL ILIAC ARTERIES/ATTACHMENT SITE(S). 5. ANEURYSM(S) EXTENDING INTO THE ILIAC ARTERIES MAY REQUIRE SPECIAL CONSIDERATION IN SELECTING A SUITABLE GRAFT/ARTERY INTERFACE SITE. 6. DEGREE OF VASCULAR CALCIFICATION 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 KINKS 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. 3. REPAIR VESSELS AND CLOSE IN STANDARD SURGICAL FASHION 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. PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAAS. PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASIS 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.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. A POTENTIAL ROOT CAUSE HAS BEEN TRACED TO PATIENT ANATOMY AND COMORBIDITY (ARTERIAL DISEASE). 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 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 A PATIENT PARTICIPATING IN A STUDY HAD A TYPE 1B ENDOLEAK THAT WAS PRESENT AT THE CONCLUSION OF THE PROCEDURE AND PERSISTED IN THE IMAGING COMPLETED SIX DAYS POST PROCEDURE. A PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2023 (102 DAYS PRIOR TO THE STUDY DEVICE PROCEDURE). THE INNOMINATE, RIGHT COMMON CAROTID, RIGHT SUBCLAVIAN, LEFT COMMON CAROTID, LEFT SUBCLAVIAN, AND THE CELIAC ARTERIES WERE INCORPORATED IN THE REPAIR. THE ARTERIES WERE PATENT AND NO VESSEL STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE RIGHT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE LEFT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE LEFT AND RIGHT COMMON ILIAC ARTERIES WERE PATENT. THE LEFT AND RIGHT INTERNAL ILIAC ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE METHOD OF LENGTH MEASUREMENT WAS CENTERLINE. THE LENGTH FROM THE SINOTUBULAR JUNCTION, OR PROXIMAL SUTURE IF ASCENDING AORTA IS REPLACED BY GRAFT, TO THE CELIAC ARTERY IS 376 MM. THE LENGTH FROM THE LOWEST RENAL ARTERY TO THE AORTIC BIFURCATION WAS 109 MM. THE INTENDED PROXIMAL LANDING ZONE WAS ZONE 5: MID DESCENDING AORTA TO THE CELIAC ARTERY. THE INTENDED DISTAL LANDING ZONE WAS ZONE 10: COMMON ILIAC ARTERIES ON THE RIGHT AND LEFT. A PRE-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024 (ONE DAY PRIOR TO THE STUDY DEVICE PROCEDURE). THE INDICATION FOR THE ELECTIVE PROCEDURE WAS AN AORTIC DEGENERATIVE ANEURYSM. THE CUSTOM MADE DEVICE (CMD) STUDY PROCEDURE WAS COMPLETED ON (B)(6) 2024 UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ASPIRIN (ACETYLSALICYLIC ACID) ANTIPLATELET THERAPY AT THE TIME OF THE PROCEDURE. THE RIGHT AND LEFT FEMORAL ARTERIES REQUIRED CUT DOWN FOR ACCESS. AN ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE CMD PROCEDURE. THE TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE WAS 108 ML. THE FLUOROSCOPY TIME WAS 64 MINUTES. THE TOTAL GRAY USED WAS 4114 MGY. THE TOTAL DOSE AREA PRODUCT WAS 334GY*CM2. FUSION WAS USED DURING THE PROCEDURE. CARDIAC OUTPUT REDUCTION WAS NOT USED. HOWEVER, CO2 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:12:09 TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 12:34 TIME OF LAST ACCESS CLOSURE: 15:12 TIME LEAVES ROOM: 12:35 (PG 76) DURATION OF PROCEDURE: 158 MINUTES A COMPETITOR'S STENT WAS PLACED IN THE CELIAC ARTERY (9 MM X 32 MM). THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCH DEVICE. THE STENT WAS NOT RELINED OR EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS CONSIDERED A TECHNICAL SUCCESS. NORMAL PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. A COMPETITOR'S STENT WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY (SMA) (9 MM X 32 MM). THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCH DEVICE. THE STENT WAS NOT RELINED OR EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS CONSIDERED A TECHNICAL SUCCESS. NORMAL PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. A COMPETITOR'S STENT WAS PLACED IN THE RIGHT RENAL ARTERY (6 MM X 22 MM). THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCH DEVICE. THE STENT WAS NOT RELINED OR EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS CONSIDERED A TECHNICAL SUCCESS. NORMAL PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. A COMPETITOR'S STENT WAS PLACED IN THE LEFT RENAL ARTERY (6 MM X 22 MM). THE ARTERY WAS REVASCULARIZED WITH THE FENESTRATED-BRANCH DEVICE. THE STENT WAS NOT RELINED OR EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WAS CONSIDERED A TECHNICAL SUCCESS. NORMAL PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. A COOK ZENITH FENESTRATED GRAFT CUSTOM MADE DEVICE (CMD), (RPN: FEN-THORACO-ABDOMINAL-GRAFT) WAS PLANNED FOR THIS PATIENT AND IMPLANTED. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE MAIN CMD DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. A COOK ZENITH FENESTRATED GRAFT CUSTOM MADE DEVICE (CMD), (RPN: AAA-FEN-BIFURCATED-GRAFT) WAS PLACED IN THE DISTAL AORTA. THE CMD WAS PLANNED FOR THIS PATIENT. THE PROXIMAL SIZE OF THE AORTIC DEVICE WAS 12 MM. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DISTAL AORTIC CMD DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. A COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT) WAS PLACED ON THE PATIENT'S LEFT. THE DISTAL DIAMETER OF THE SEAL STENT WAS 20 MM. THE LENGTH OF THE DEVICE WAS 56 MM. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. A COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT) WAS PLACED ON THE PATIENT'S RIGHT. THE DISTAL DIAMETER OF THE SEAL STENT WAS 20 MM. THE LENGTH OF THE DEVICE WAS 56 MM. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICE. THE DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. A COOK LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE (RPN: TSCMG-35-260-LESDC) WAS USED IN THE CONTRALATERAL ACCESS SITE. THE TARGET VESSEL WAS THE ABDOMINAL AORTA. THE DEVICE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED. NO DEVICE DEFICIENCIES WERE IDENTIFIED. A COOK LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE (RPN: TSCMG-35-260-LESDC) WAS USED IN THE CONTRALATERAL ACCESS SITE. THE TARGET VESSEL WAS THE ABDOMINAL AORTA. THE DEVICE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED. NO DEVICE DEFICIENCIES WERE IDENTIFIED. A COOK CODA LP BALLOON CATHETER (RPN: CODA-2-9.0-35-120-32) WAS USED FOR BALLOONING IN THE ABDOMINAL AORTA GRAFT JUNCTION. THE DEVICE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED. NO DEVICE DEFICIENCIES WERE IDENTIFIED. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS CONSIDERED A TECHNICAL SUCCESS. NO ADDITIONAL PROCEDURES WERE PREFORMED DURING THE STUDY CMD PROCEDURE. AN ANGIOGRAM WAS COMPLETED DURING THE PROCEDURE ON 23FEB2024. ALL STENT GRAFTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. ALL TARGET VESSELS WERE PATENT. THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL TARGET SIDE BRANCH STENTS WERE INTACT. THERE WERE 2 -2.9 STENTS OVERLAP BETWEEN THE DISTAL DEVICE AND THE ADDITIONAL DISTAL DEVICE. THE OVERLAP BETWEEN THE DISTAL DEVICE AND THE ADDITIONAL DEVICE WAS NOT BRIDGED WITH AN ADDITIONAL THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) DEVICE. A TYPE 1B ENDOLEAK ON THE MOST DISTAL RIGHT ILIAC COMPONENT AND A TYPE IIIC ENDOLEAK FROM THE RIGHT RENAL STENT WERE IDENTIFIED. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND DID NOT REQUIRE REINTUBATION. THE PATIENT STAYED IN THE INTENSIVE CARE UNIT FOR ONE NIGHT. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2024. ALL STENT GRAFTS WERE PATENT. NO OCCLUSIONS OR STENOSIS GREATER THAN 50 % WAS IDENTIFIED IN THE CELIAC, SMA, RIGHT RENAL, OR LEFT RENAL ARTERY. THE MAXIMUM DIAMETER OF THE DISEASED AORTA WAS 60 MM. THE LENGTH FROM SINOTUBULAR JUNCTION TO THE MOST PROXIMAL CIRCUMFERENTIAL VISUALIZATION OF METAL IN THE GRAFT WAS 363 MM. THE LENGTH FROM LEFT COMMON CAROTID ARTERY TO THE MOST PROXIMAL CIRCUMFERENTIAL VISUALIZATION OF METAL IN THE GRAFT WAS 256 MM. THE LENGTH FROM THE SMA TO THE FIRST VISUALIZATION OF THE MOST DISTAL CIRCUMFERENTIAL VISUALIZATION OF METAL IN THE GRAFT WAS 176MM. ALL STENT GRAFTS WERE PATENT AND THERE WAS NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES. ALL INTENDED SIDE BRANCH STENTS WERE INTACT. A PERSISTENT TYPE 1B ENDOLEAK ON THE MOST DISTAL ILIAC COMPONENT ON THE RIGHT WAS IDENTIFIED. ADDITIONALLY A PERSISTENT TYPE II ENDOLEAK AND A TYPE IIIC ENDOLEAK FROM THE BRANCH COMPONENT AT THE RENAL ARTERY WAS IDENTIFIED. NO SECONDARY INTERVENTION WAS PERFORMED TO ADDRESS THE ENDOLEAK. A ONE MONTH CLINICAL ASSESSMENT WAS COMPLETED ON (B)(6) 2024 (6 DAYS POST PROCEDURE). THE PATIENTS CURRENT MEDICATIONS WERE ASPIRIN (ASA), AND ANTIPLATELET, AND A STATIN. SINCE THE LAST VISIT THE PATIENT HAD NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS NOR HAD HE BEEN HOSPITALIZED FOR ANY REASON. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. AT DISCHARGE THE PATIENT WAS PRESCRIBED THE FOLLOWING MEDICATIONS: ACETYLSALICYLIC ACID (ASA), CLOPIDOGREL, AND A STATIN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. THE FOCUS OF THIS REPORT IS THE TYPE 1B ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT PLACED ON THE RIGHT THAT WAS IDENTIFIED AT THE CONCLUSION OF THE CMD PROCEDURE AND PERSISTED IN THE FOLLOW UP IMAGING COMPLETED 5 DAYS POST PROCEDURE. NO ADDITIONAL PROCEDURE WAS COMPLETED TO ADDRESS THE ENDOLEAK AT THE TIME OF THIS REPORT. THE PATIENT WILL BE FOLLOWED IN THE STUDY FOLLOW UP PROGRAM.
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 |
|---|---|---|---|---|---|---|---|
| 1985769 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 15727168 | 10827002552415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | ADVANTA V12 (6 MM X 22 MM)| ADVANTA V12 (9 MM X 32 MM)| COOK AAA-FEN-BIFURCATED-GRAFT, LOT AC1150291| COOK FEN-THORACO-ABDOMINAL-GRAFT, LOT AC1150291| COOK TSCMG-35-260-LESDC, LOT E4502059| COOK TSCMG-35-260-LESDC, LOT E4502468| COOK ZSLE-20-56-ZT, LOT 15726012 |