ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2023-01179
- Event Type
- Injury
- Date Received
- August 31, 2023
- Report Date
- October 16, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002484327
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D6A (IMPLANT DATE) : 2014. E3: VASCULAR SURGEON. 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. INVESTIGATION ¿ EVALUATION (B)(6) HOSPITAL INFORMED COOK ON 23AUG2023 OF AN INCIDENT INVOLVING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-36-95-ZT) FROM LOT 4053084. THE MALE PATIENT (UNKNOWN AGE) HAD AN INITIAL EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE COMPLETED IN 2017. IN 2020 REINTERVENTION WAS COMPLETED FOR LOSS OF WALL CONTACT OF THE PROXIMAL STENT. ACCORDING TO THE SITE THIS WAS DUE TO ANEURYSMAL DISEASE. A CT SCAN WAS COMPLETED ON (B)(6) 2023 AND AT AN UNKNOWN DATE AN ULTRASOUND BUBBLE TEST WAS PERFORMED. THE SITE INITIALLY SUSPECTED A FABRIC TEAR OF THE DISTAL END LIMB, SO IT WAS PLANNED TO RELINE THE GRAFT. HOWEVER, DURING REINTERVENTION WITH RELINING THE LIMB IT WAS NOTED THAT THE BRIDGING LIMB HAD COMPLETELY DISCONNECTED FROM THE MAIN BODY THEREFORE CAUSING A TYPE 3A ENDOLEAK. RELINING WAS COMPLETED AND THE ENDOLEAK RESOLVED. MDR #1820334-2023-01178 CAPTURES THE TYPE 3A ENDOLEAK OF THE ZSLE-16-56-ZT LEG GRAFT. THIS COMPLAINT CAPTURES THE LOSS OF WALL APPOSITION (TYPE 1A ENDOLEAK) AND TYPE 3A ENDOLEAK OF THE MAIN BODY. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, MEDICAL IMAGING WAS PROVIDED BY THE CUSTOMER FOR EXPERT REVIEW. AN INFRARENAL AORTO-ILIAC ANEURYSM WAS PREVIOUSLY TREATED USING A TFFB-36-95 MAIN BODY GRAFT, A CONTRALATERAL ZSLE-16-56 BRIDGING LEG WITH A ZBIS-10-45-41 BRANCH GRAFT ON THE RIGHT, AND AN IPSILATERAL ZSLE-20-56 LEG ON THE LEFT. PER THE REPORT, A TYPE 1A ENDOLEAK DUE TO DISEASE PROGRESSION DEVELOPED AROUND THE PROXIMAL TFFB GRAFT AT 6 YEARS POSTOP (2020). THIS IS NOT DEMONSTRATED ON THE IMAGING PROVIDED AND IS BASED SOLELY ON THE REPORT. PROXIMAL EXTENSION WAS PERFORMED USING A FENESTRATED-THORACOABDOMINAL GRAFT WITH ADEQUATE PROXIMAL SEAL AND NO TYPE 1A ENDOLEAK SEEN AT 9 YEARS ON THE IMAGING PROVIDED. AT 9 YEARS, THERE IS COMPLETE SEPARATION AND LOSS OF OVERLAP BETWEEN THE CONTRALATERAL LIMB OF THE TFFB GRAFT AND THE PROXIMAL RIGHT ZSLE (16 X 56 MM) LEG, RESULTING IN A TYPE 3A ENDOLEAK. GIVEN THE POSTOP TIMEFRAME AND PREVIOUS REPORT OF DISEASE PROGRESSION, THIS COULD BE DUE TO AORTIC ELONGATION. IT IS UNCLEAR HOW MUCH SAC DIAMETER GROWTH THERE HAS BEEN FROM THE INITIAL IMPLANT, BUT INCREASED DIAMETER ALONE COULD HAVE AFFECTED THE GRAFT CONFORMATION/POSITION BY GRADUALLY CONFORMING TO THE OUTER ANTERIOR CURVE OF THE ENLARGING AAA SAC, RESULTING IN SIGNIFICANT OUTWARD BENDING OF THE GRAFT AND ANGULATION AT THE LIMBS AND THUS ELONGATING THE GRAFT-CENTERLINE DISTANCE FROM THE RENALS TO THE ILIACS. THE ANATOMIC CENTERLINE DISTANCE FROM THE PROXIMAL TFFB GRAFT TO THE DISTAL ZBIS GRAFT THROUGH THE AAA SAC IS 196 MM ON THE CT PROVIDED, WHILE THE TRUE GRAFT CENTERLINE DISTANCE WITH ITS CURRENT POSITIONING IS 238 MM. IF THIS POSITION WAS A SHIFT FROM THE INITIAL PLACEMENT, IT COULD HAVE CAUSED GRADUAL DISTRACTION OF THE COMPONENTS WITH LOSS OF OVERLAP, AS ON THE RIGHT SIDE. THIS MIGHT HAVE ALSO CAUSED RETRACTION OF THE LEFT ZSLE LEG INTO THE PROXIMAL-MID LEFT CIA WITH DECREASED COVERAGE AND LOSS OF GRAFT WALL APPOSITION HERE. HOWEVER, EARLY POSTOP IMAGING WOULD BE NEEDED TO COMPARE THE COMPONENT POSITIONS AND APPEARANCE TO CONFIRM THIS. INCIDENTALLY, THERE IS A LIMITED TYPE 1B ENDOLEAK AROUND THE DISTAL EDGE OF THE LEFT ZSLE LEG DUE TO LACK OF GRAFT WALL APPOSITION IN THE PROXIMAL TO MID LEFT CIA. THE ENDOLEAK DOES NOT EXTEND PROXIMALLY, BUT THERE IS A HIGH RISK FOR LOSS OF DISTAL SEAL HERE. THIS COULD BE DUE TO PROXIMAL MIGRATION/RETRACTION OF THE LEFT ZSLE LEG WITH REDUCED COVERAGE IN THE LEFT CIA DUE TO AORTIC ELONGATION OR SHIFT IN TFFB GRAFT/LIMB POSITIONING IN THE AAA SAC, AS NOTED ABOVE. AGAIN, EARLY POSTOP IMAGING WOULD BE NEEDED TO COMPARE WITH THE INITIAL LEFT ZSLE POSITION TO CONFIRM THIS. 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 4053084 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RELEVANT NON-CONFORMANCES. 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 FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_ZAAAF_REV 4 ¿ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE Z-TRAK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 1 DEVICE DESCRIPTION 1.1 AORTIC MAIN BODY AND ILIAC LEG COMPONENTS THE MODULES ARE FULLY STENTED TO PROVIDE STABILITY AND THE EXPANSILE FORCE NECESSARY TO OPEN THE LUMEN OF THE GRAFT DURING DEPLOYMENT. ADDITIONALLY, THE COOK-Z STENTS PROVIDE THE NECESSARY ATTACHMENT AND SEAL OF THE GRAFT TO THE VESSEL WALL. THE BARE SUPRARENAL STENT AT THE PROXIMAL END OF THE GRAFT CONTAINS BARBS THAT ARE PLACED AT 3 MM INCREMENTS FOR ADDITIONAL FIXATION OF THE DEVICE. TO FACILITATE FLUOROSCOPIC VISUALIZATION OF THE STENT GRAFT, GOLD RADIOPAQUE MARKERS ARE POSITIONED AS FOLLOWS: ONE ON THE LATERAL ASPECT OF THE MOST DISTAL STENT ON THE CONTRALATERAL LIMB OF THE BIFURCATED SECTION OF THE MAIN BODY AND FOUR IN A CIRCUMFERENTIAL ORIENTATION WITHIN 2 MM OF THE MOST SUPERIOR ASPECT OF THE GRAFT MATERIAL. 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 AN ENLARGING ANEURYSM, 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 ¿ THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT AORTIC NECK DIAMETERS NO SMALLER THAN 18 MM AND NO LARGER THAN 32 MM. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT PROXIMAL AORTIC NECKS (DISTAL TO THE LOWEST RENAL ARTERY) OF AT LEAST 15 MM IN LENGTH. ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 - 20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. ¿ KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION (>60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR >45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (<15 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC NECK LENGTH); AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IN THE PRESENCE OF ANATOMICAL LIMITATIONS, A LONGER NECK MAY BE REQUIRED TO OBTAIN ADEQUATE SEALING AND FIXATION. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE ATTACHMENT AND SEALING AT THE FIXATION SITES. NECKS EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK. ¿ 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 16 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS, OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ¿ 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. DIAMETERS UTILIZING CT, DIAMETER MEASUREMENTS SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER (NOT LUMEN MEASUREMENT) TO HELP WITH PROPER DEVICE SIZING AND DEVICE SELECTION. THE CONTRAST-ENHANCED SPIRAL CT SCAN MUST START 1 CM SUPERIOR TO THE CELIAC AXIS AND CONTINUE THROUGH THE FEMORAL HEADS AT AN AXIAL THICKNESS SLICE OF 3 MM OR LESS. 4.4 DEVICE SELECTION ¿ STRICT ADHERENCE TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLES 10.5.1 THROUGH 10.5.2). 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 ¿ APPROPRIATE PROCEDURAL IMAGING IS REQUIRED TO SUCCESSFULLY POSITION THE ZENITH FLEX AAA ENDOVASCULAR GRAFT AND ASSURE ACCURATE APPOSITION TO THE AORTIC WALL. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ENDOLEAK ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION 7 PATIENT SELECTION AND TREATMENT 7.1 INDIVIDUALIZATION OF TREATMENT THE RISKS AND BENEFITS SHOULD BE CAREFULLY CONSIDERED FOR EACH PATIENT BEFORE USE OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: ¿ PATIENT'S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR ¿ NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: ¿ WITH A LENGTH OF AT LEAST 15 MM, ¿ WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 32 MM AND NO LESS THAN 18 MM, ¿ WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND ¿ WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA ¿ ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 TO 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 PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. 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 10.5 DEVICE SIZING GUIDELINES THE CHOICE OF DIAMETER SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER AND NOT THE LUMEN DIAMETER. UNDERSIZING OR OVERSIZING MAY RESULT IN INCOMPLETE SEALING OR COMPROMISED FLOW. 11 DIRECTIONS FOR USE ANATOMICAL REQUIREMENTS ¿ PROXIMAL AORTIC NECK LENGTHS SHOULD BE A MINIMUM OF 15 MM WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF 18 ¿ 32 MM. PRE-IMPLANT DETERMINANTS VERIFY FROM PRE-IMPLANT PLANNING THAT THE CORRECT DEVICE HAS BEEN SELECTED. DETERMINANTS INCLUDE: 1. FEMORAL ARTERY SELECTION FOR INTRODUCTION OF THE MAIN BODY SYSTEM (I.E., DEFINE RESPECTIVE CONTRALATERAL AND IPSILATERAL ILIAC ARTERIES). 2. ANGULATION OF AORTIC NECK, ANEURYSM, AND ILIAC ARTERIES. 3. QUALITY OF THE AORTIC NECK. 4. DIAMETERS OF INFRARENAL AORTIC NECK AND DISTAL ILIAC ARTERIES. 5. DISTANCE FROM RENAL ARTERIES TO THE AORTIC BIFURCATION. 6. LENGTH FROM THE AORTIC BIFURCATION TO THE INTERNAL ILIAC ARTERIES/ATTACHMENT SITE(S). 7. ANEURYSM(S) EXTENDING INTO THE ILIAC ARTERIES MAY REQUIRE SPECIAL CONSIDERATION IN SELECTING A SUITABLE GRAFT/ARTERY INTERFACE SITE. 8. CONSIDER THE 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. 12.4 ULTRASOUND ULTRASOUND IMAGING MAY BE PERFORMED IN PLACE OF CONTRAST CT WHEN PATIENT FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA. ULTRASOUND MAY BE PAIRED WITH NON-CONTRAST CT. A COMPLETE AORTIC DUPLEX IS TO BE VIDEOTAPED FOR MAXIMUM ANEURYSM DIAMETER, ENDOLEAKS, STENT PATENCY AND STENOSIS. INCLUDED ON THE VIDEOTAPE SHOULD BE THE FOLLOWING INFORMATION AS OUTLINED BELOW: ¿ TRANSVERSE AND LONGITUDINAL IMAGING SHOULD BE OBTAINED FROM THE LEVEL OF THE PROXIMAL AORTA DEMONSTRATING MESENTERIC AND RENAL ARTERIES TO THE ILIAC BIFURCATIONS TO DETERMINE IF ENDOLEAKS ARE PRESENT UTILIZING COLOR FLOW AND COLOR POWER ANGIOGRAPHY (IF ACCESSIBLE). ¿ SPECTRAL ANALYSIS CONFIRMATION SHOULD BE PERFORMED FOR ANY SUSPECTED ENDOLEAKS. ¿ TRANSVERSE AND LONGITUDINAL IMAGING OF THE MAXIMUM ANEURYSM SHOULD BE OBTAINED. BASED ON THE INFORMATION PROVIDED, EXPERT REVIEW OF MEDICAL IMAGING PROVIDED BY THE FACILITY, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE MODE COULD NOT BE DETERMINED. IT IS LIKELY PATIENT CONDITION/ANATOMY WAS A LIKELY CONTRIBUTING FACTOR AS WELL AS PROGRESSION OF THE ANEURYSMAL DISEASE. THE IMAGE REVIEWER STATED, ¿AT 9 YEARS, THERE IS COMPLETE SEPARATION AND LOSS OF OVERLAP BETWEEN THE CONTRALATERAL LIMB OF THE TFFB GRAFT AND THE PROXIMAL RIGHT ZSLE (16 X 56 MM) LEG, RESULTING IN A TYPE 3A ENDOLEAK.¿ ACCORDING TO THE SITE IN 2020 THERE WAS A TYPE 1A ENDOLEAK DUE TO PROGRESSION OF ANEURYSMAL DISEASE. THE IMAGE REVIEWER NOTED ¿GIVEN THE POSTOP TIMEFRAME AND PREVIOUS REPORT OF DISEASE PROGRESSION, THE COMPONENT SEPARATION AND TYPE 3A ENDOLEAK COULD BE DUE TO AORTIC ELONGATION.¿ ADDITIONALLY, IT WAS NOTED IN THE IMAGE REVIEW ¿IT IS UNCLEAR HOW MUCH SAC DIAMETER GROWTH THERE HAS BEEN FROM THE INITIAL IMPLANT, BUT INCREASED DIAMETER ALONE COULD HAVE AFFECTED THE GRAFT CONFORMATION/POSITION BY GRADUALLY CONFORMING TO THE OUTER ANTERIOR CURVE OF THE ENLARGING AAA SAC, RESULTING IN SIGNIFICANT OUTWARD BENDING OF THE GRAFT AND ANGULATION AT THE LIMBS AND THUS ELONGATING THE GRAFT-CENTERLINE DISTANCE FROM THE RENALS TO THE ILIACS. THE ANATOMIC CENTERLINE DISTANCE FROM THE PROXIMAL TFFB GRAFT TO THE DISTAL ZBIS GRAFT THROUGH THE AAA SAC IS 196 MM ON THE CT PROVIDED, WHILE THE TRUE GRAFT CENTERLINE DISTANCE WITH ITS CURRENT POSITIONING IS 238 MM. IF THIS POSITION WAS A SHIFT FROM THE INITIAL PLACEMENT, IT COULD HAVE CAUSED GRADUAL DISTRACTION OF THE COMPONENTS WITH LOSS OF OVERLAP, AS ON THE RIGHT SIDE.¿ 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 TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IN 2014 A PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WHERE THE FOLLOWING COOK GRAFTS WERE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT , LOT NUMBER 4053084); ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT NUMBER A937127) ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 4715582); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 4792180). IN 2020 A REINTERVENTION PROCEDURE WAS COMPLETED. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT LOT NUMBER 4053084) LOST WALL APPOSITION PROXIMALLY CREATING A TYPE 1A ENDOLEAK. A FENESTRATED TUBE GRAFT (MANUFACTURER UNKNOWN) WAS PLACED DURING THE SECONDARY PROCEDURE. A COMPUTED TOMOGRAPHY SCAN WAS COMPLETED ON (B)(6) 2023 AND AN ENDOLEAK WAS NOTED AND THOUGHT TO BE A TYPE 3B ENDOLEAK. AN ULTRASOUND BUBBLE TEST WAS ALSO PERFORMED AFTER THE REINTERVENTION PROCEDURE IN 2020. ON (B)(6) 2023 A REINTERVENTION PROCEDURE WAS COMPLETED WITH THE INTENTION TO RELINE THE DISTAL END OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 4053084) AS IT WAS THOUGHT THAT A FABRIC TEAR WAS PRESENT. HOWEVER, DURING THE PROCEDURE IT WAS DISCOVERED THAT THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 4053084) HAD COMPLETELY SEPARATED FROM THE BRIDGING LIMB, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 4715582). A NEW LIMB WAS PLACED TO SEAL BETWEEN THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 4053084) AND THE ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT NUMBER A937127) TO RESOLVE THE ENDOLEAK. THE FOCUS OF THIS REPORT IS THE TYPE 1A AND TYPE 3A ENDOLEAKS ON THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT ,LOT NUMBER 4053084) THAT REQUIRED REINTERVENTION IN 2020 AND 2023. AN ADDITIONAL REPORT FOR THE TYPE 3A ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 4715582) WILL BE SUBMITTED WITH THE PATIENT IDENTIFIER 406759.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1514400 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 4053084 | 10827002484327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | COOK RPN: ZSLE-16-56-ZT, LOT 4715582| COOK RPN: ZSLE-20-56-ZT, LOT 4792180| COOK RPN:ZBIS-10-45-41, LOT A937127 |