ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2020-01068
- Event Type
- Injury
- Date Received
- June 4, 2020
- Date of Event
- February 27, 2020
- Report Date
- December 10, 2020
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552316
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. ADDITIONAL INFORMATION: SECTION C. CORRECTION: PRODUCT IDENTIFIER, : RPN, LOT. INVESTIGATION ¿ EVALUATION. DR. (B)(6) FROM (B)(6) HOSPITAL IN THE UNITED STATES INFORMED COOK ON (B)(6) 2020 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-9-122-ZT FROM LOT: 9362305. IT WAS REPORTED THAT THE LEFT ILIAC LEG GRAFT WAS OCCLUDED BY THROMBUS FORMATION 86 DAYS POST IMPLANTATION ON 27FEB2020. THE 71 YEAR OLD MALE PATIENT WAS ENROLLED IN THE CLINICAL STUDY: 14-09 ZENITH P-BRANCH PIVOTAL STUDY. THE PATIENT'S PRE-EXISTING CONDITIONS INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, GASTRIC ULCER, AND WAS A SMOKER. HE HAD A PREVIOUS MYOCARDIAL INFARCTION THAT WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH STENT PLACEMENT. THE PATIENT HAD A STABLE JUXTARENAL ANEURYSM THAT MEASURED 55.6 MM IN DIAMETER. ON (B)(6) 2019 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) AND RECEIVED A ZENITH P-BRANCH ENDOVASCULAR GRAFT (RPN: P-BRANCH-30-22-A LOT: A1018859), ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT (RPN: UNIBODY-24-81, LOT: A1045387), LEFT ZSLE-9-122-ZT LOT: 9362305) PLACED ON THE LEFT AND ZSLE-16-74-ZT LOT: 9995501) PLACED ON THE RIGHT. THREE NON-COOK DEVICES WERE ALSO IMPLANTED INCLUDING A SUPERIOR MESENTERIC ARTERY COVERED STENT AND BILATERAL COVERED STENTS IN THE LEFT AND RIGHT RENAL ARTERIES. A MOLDING BALLOON WAS NOT USED DURING THE PROCEDURE. THE SITE REPORTED THAT THE COMPLETION ANGIOGRAM SHOWED PATENT DEVICES AND NO EVIDENCE OF AN ENDOLEAK. THE PATIENT WAS DISCHARGED ON 05DEC2019 AND WAS REPORTED TO BE TAKING ANTI-COAGULANTS (NO MEDICATION SPECIFIED) AT THE TIME OF DISCHARGE. ON (B)(6) 2020 (86 DAYS POST-PROCEDURE), THE PATIENT WAS DIAGNOSED WITH OCCLUSION OF THE LEFT AND RIGHT RENAL STENTS WITH BILATERAL RENAL INFARCT. THE RENAL OCCLUSIONS WERE TREATED BY THROMBECTOMY AND ADDITIONAL STENT PLACEMENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION OF THE LEFT ILIAC LEG GRAFT (ZSLE-9-122-ZT). THE OCCLUSION WAS TREATED WITH A FEMORAL-FEMORAL BYPASS PROCEDURE. THE SITE REPORTED THAT THE DEVICE DID NOT DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. THE SITE DETERMINED THAT THE ILIAC GRAFT OCCLUSION TO BE ¿POSSIBLY¿ RELATED TO THE STUDY PRODUCT AND ¿DEFINITELY¿ RELATED TO STUDY PROCEDURE. IT WAS REPORTED THAT THE LEFT ILIAC LEG GRAFT WAS OCCLUDED BY THROMBUS FORMATION 86 DAYS POST IMPLANTATION ON (B)(6) 2020. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHF), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATIONS WERE CONDUCTED. HOWEVER, A PREOPERATIVE CT DATED FROM (B)(6) 2019 WAS REVIEWED BY AN EXPERT IMAGE REVIEWER. THROMBUS OCCLUSION OF THE LEFT ZSLE-9-122-ZT COULD NOT BE OBSERVED ON THE PRE-OPERATIVE IMAGING PROVIDED. POSSIBLE CONTRIBUTING FACTORS IDENTIFIED INCLUDED SIGNIFICANT TORTUOSITY OF THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY (EIA), NOT BALLOON EXPANDING THE GRAFT DURING THE PROCEDURE AND PATIENT CONDITION. THE REVIEWER STATED THAT THE LEFT COMMON ILIAC ARTERY (CIA) WAS ANEURYSMAL; THEREFORE, THE LEFT ZSLE-9-122 GRAFT WAS LIKELY PLACED INTO THE LEFT EIA FOR DISTAL SEAL AND EXCLUSION OF THE CIA ANEURYSM. THE PROXIMAL SEGMENT OF THE LEFT EIA HAD SIGNIFICANT TORTUOSITY, WHICH COULD HAVE CONTRIBUTED TO THROMBUS FORMATION RESULTING FROM GRAFT COMPRESSION, ANGULATION/KINK AND FLOW DISTURBANCE THROUGH THE DISTAL GRAFT. COOK HAS CONCLUDED THAT PRODUCT WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DESIGN HISTORY FILE (DHF) FOUND THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 9362305 FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS LOT. BECAUSE THERE ARE ADEQUATE INSPECTION ACTIVITIES IN PLACE, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES, AND NO OTHER LOT-RELATED COMPLAINTS RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 4 WARNINGS AND PRECAUTIONS 4.1 GENERAL ¿ 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 ¿ 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 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. ¿ PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20 MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ADDITIONALLY, THE COMPLETION ANGIOGRAM (WITH STIFF WIRE GUIDES REMOVED) SHOULD BE REVIEWED CAREFULLY TO DETERMINE IF FURTHER TREATMENT IN THESE REGIONS IS NECESSARY (E.G., ADJUNCTIVE BALLOONING OR STENTING). FAILURE TO REMOVE THE STIFF WIRE GUIDE PRIOR TO THE ANGIOGRAM COULD MASK ANY LIMB KINKING OR NARROWING THAT MIGHT OCCUR WHEN THE WIRE GUIDE IS REMOVED. ¿ FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5 MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). REINTERVENTION (E.G., NONCOMPLIANT BALLOONING OR STENTING IN THESE REGIONS) SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ¿ PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. ¿ THE ZENITH SPIRAL-Z AAA ILIAC LEG HAS NOT BEEN EXPLICITLY EVALUATED CLINICALLY; HOWEVER ITS PERFORMANCE IS REPRESENTED BY THE ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG (A PREVIOUS VERSION OF THE DEVICE), WHICH HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: ¿¿ KEY ANATOMICAL ELEMENTS THAT FALL OUTSIDE THE SIZING REQUIREMENTS SPECIFIED IN THE APPROPRIATE MAIN BODY OR RENU INSTRUCTIONS FOR USE. 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 ¿ SYSTEMIC ANTICOAGULATION SHOULD BE USED DURING THE IMPLANT PROCEDURE BASED ON HOSPITAL- AND PHYSICIAN-PREFERRED PROTOCOL. IF HEPARIN IS CONTRAINDICATED, AN ALTERNATIVE ANTICOAGULANT SHOULD BE CONSIDERED. ¿ USE CAUTION DURING MANIPULATION OF CATHETERS, WIRES AND SHEATHS WITHIN AN ANEURYSM. SIGNIFICANT DISTURBANCES MAY DISLODGE FRAGMENTS OF THROMBUS, WHICH CAN CAUSE DISTAL EMBOLIZATION, OR MAY RUPTURE THE ANEURYSM. ¿ EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. 5 ADVERSE EVENTS 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM ¿ CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) ¿ EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION ¿ ENDOPROSTHESIS: OCCLUSION ¿ GRAFT OR NATIVE VESSEL OCCLUSION ¿ RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE) 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 SPIRAL-Z AAA ILIAC LEG. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ PATIENT¿S AGE AND LIFE EXPECTANCY ¿ CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY) THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 8 PATIENT COUNSELING INFORMATION ¿ PHYSICIANS MUST ADVISE ALL PATIENTS THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG¿ DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE AND DEATH. 11 DIRECTIONS FOR USE ANATOMICAL REQUIREMENTS ¿ ILIOFEMORAL ACCESS SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES. ARTERIAL CONDUIT TECHNIQUES MAY BE REQUIRED. 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM 11.1.4 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. INTRODUCE THE CONTRALATERAL ILIAC LEG DELIVERY SYSTEM INTO THE ARTERY. ADVANCE SLOWLY UNTIL AT LEAST ONE STENT OF THE ILIAC LEG GRAFT OVERLAPS WITHIN THE MAIN BODY AND NOT PAST THE RADIOPAQUE MARKER BAND POSITIONED 30 MM FROM THE PROXIMAL END OF THE ILIAC LEG GRAFT INSIDE THE CONTRALATERAL LIMB OF THE MAIN BODY. IF THERE IS ANY TENDENCY FOR THE MAIN BODY GRAFT TO MOVE DURING THIS MANEUVER, HOLD IT IN POSITION BY STABILIZING THE GRAY POSITIONER ON THE IPSILATERAL SIDE. 4. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY, A MINIMUM OVERLAP OF ONE STENT, AND A MAXIMUM OVERLAP OF 30 MM WITHIN THE MAIN BODY ENDOVASCULAR GRAFT. 11.1.5 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT NOTE: IF USING THIS DEVICE IN CONJUNCTION WITH A ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT OR ZENITH LOW PROFILE ENDOVASCULAR GRAFT, PROCEED TO SECTION 11.1.16, IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT IN CONJUNCTION WITH ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT OR ZENITH LOW PROFILE ENDOVASCULAR GRAFT. FOR ALL OTHER SYSTEMS, CONTINUE WITH STEPS 1-7 BELOW. 2. ADVANCE SLOWLY UNTIL THE IPSILATERAL ILIAC LEG GRAFT OVERLAPS A MINIMUM OF ONE STENT INSIDE THE IPSILATERAL LIMB OF THE MAIN BODY. 3. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY. 11.1.6 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT IN CONJUNCTION WITH ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT OR ZENITH LOW PROFILE ENDOVASCULAR GRAFT 4. INTRODUCE THE IPSILATERAL ILIAC LEG DELIVERY SYSTEM, AND CONTINUE ADVANCING SLOWLY UNTIL THE PROXIMAL EDGE OF THE IPSILATERAL LEG GRAFT ALIGNS WITH THE PROXIMAL EDGE OF THE PREVIOUSLY-PLACED CONTRALATERAL LEG GRAFT. 5. CONFIRM POSITION OF THE DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE INTERNAL ILIAC PATENCY. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF PROVIDED IMAGING AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE IMPLANT PROCEDURE AND PATIENT CONDITION LIKELY INCREASED THE RISK FOR THROMBUS FORMATION. THROMBUS FORMATION IS ALSO LISTED AS A POTENTIAL ADVERSE EFFECT IN THE PRODUCT IFU AND IS A KNOWN INHERENT RISK FOR THIS DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
CONCOMITANT PRODUCTS: P-BRANCH-30-22-A LOT # A1018859, UNIBODY-24-81 LOT # A1045387, ZSLE-9-122-ZT LOT # 9312188 LEFT ILIAC LEG, ZSLE-16-74-ZT LOT # 9995501 RIGHT ILIAC LEG, SMA COVERED STENT 7 MM X 22 MM (ATRIUM, LOT# 450188046), RIGHT RENAL COVERED STENT 6 MM X 22 MM (ATRIUM LOT# 448461041), LEFT RENAL COVERED STENT 6 MM X 22 MM (ATRIUM LOT# 448461042). CUSTOMER (PERSON): EMAIL - (B)(6). (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
IT WAS REPORTED THAT AN OCCLUSION WAS DISCOVERED IN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE INITIAL EVAR PROCEDURE WAS COMPLETED ON (B)(6) 2019. CORE LAB ANALYSIS OF THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE DEVICES WERE PATENT WITH NO EVIDENCE OF ENDOLEAKS. THE PATIENT'S ESTIMATED BLOOD LOSS WAS 200CC, WITH NO BLOOD PRODUCTS BEING ADMINISTERED INTRA-OPERATIVELY. NO DIFFICULTIES WERE NOTED DURING THE ORIGINAL PROCEDURE. THE PATIENT WAS TAKING ANTICOAGULANTS UPON HOSPITAL DISCHARGE ON (B)(6) 2019. AT A FOLLOW UP VISIT ON (B)(6) 2019, 27 DAYS POST-PROCEDURE, A CT SCAN WAS PERFORMED. SITE ANALYSIS REVEALED PATENT DEVICES WITH NO EVIDENCE OF ENDOLEAKS OR DEVICE INTEGRITY ISSUES. CORE LAB ANALYSIS CONCURRED WITH THE SITE ASSESSMENT. ON (B)(6) 2020, 86 DAYS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION IN BOTH THE RIGHT AND LEFT RENAL STENT, LEADING TO A BILATERAL RENAL INFARCT. THESE RENAL OCCLUSIONS WERE TREATED WITH A THROMBECTOMY AND ADDITIONAL STENT PLACEMENT. IMAGING IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES AN OCCLUSION FOUND IN LEFT ILIAC GRAFT LEG ON (B)(6) 2020. THE OCCLUSION WAS TREATED WITH A FEMORAL-FEMORAL BYPASS. IMAGING IS CURRENTLY UNAVAILABLE. THE EVENT IS CONSIDERED "POSSIBLY" RELATED TO THE STUDY PRODUCT AND "DEFINITELY" RELATED TO THE STUDY PROCEDURE. IT WAS NOTED BY THE SITE THAT THE DEVICE DID NOT DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. THE PATIENT IS CURRENTLY HOSPITALIZED AND REMAINS IN THE STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584833 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 9362305 | 10827002552316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |