ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2023-00852
- Event Type
- Injury
- Date Received
- June 29, 2023
- Date of Event
- June 16, 2023
- Report Date
- September 12, 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
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION: STEEL MEMORIAL MURORAN HOSPITAL INFORMED COOK ON 23JUN2023 OF AN INCIDENT INVOLVING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-36-95-ZT) LOT 6760553. THE PATIENT (UNKNOWN GENDER AND AGE) HAD AN INITIAL EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE COMPLETED JULY 2016. THE FOLLOWING DEVICES WERE DEPLOYED: TFFB-36-95-ZT (LOT#: 6760553), A ZSLE-20-74-ZT (LOT#: 6993096) PLACED IN THE RIGHT ILIAC ARTERY AND A ZSLE-20-74-ZT (LOT#: 6409808) PLACED IN THE LEFT ILIAC ARTERY. ON 16JUN2023 THE PATIENT HAD A FOLLOW-UP CT (COMPUTED TOMOGRAPHY) COMPLETED. THE CT REVEALED ENLARGEMENT OF THE ANEURYSM DIAMETER IN THE ABDOMINAL REGION. ACCORDING TO THE SITE AN ECHOCARDIOGRAPHY ALSO CONFIRMED THAT THERE WAS AN AREA THAT APPEARED TO HAVE INFLUX INTO THE ANEURYSM FROM A LOCALIZED LOCATION FROM THE MAIN BODY (TFFB-36-95-ZT). THE PHYSICIAN STATED ¿I SUSPECT A FRACTURE OF THE DEVICE ITSELF, AS THERE APPEARS TO BE INFLUX FROM THE MAIN BODY LOCALLY INTO THE ANEURYSM AS FAR AS I CAN SEE ON CT AND ECHOCARDIOGRAPHY. IT IS POSSIBLE THAT ANOTHER TYPE 2 ENDOLEAK ALSO CONTRIBUTES SOMEWHAT TO ANEURYSM DIAMETER EXPANSION.¿ THE REP AGREES WITH THE PHYSICIAN THAT IT IS LIKELY A TYPE 3B ENDOLEAK. THE REP ALSO STATED, ¿SINCE THE LOCATION OF THE ENDOLEAK WAS AT THE UPPER END OF THE ANEURYSM, THE POSSIBILITY OF A TYPE 1A OR TYPE 2 ENDOLEAK FROM A BRANCH CANNOT BE RULED OUT, BUT SINCE THERE APPEARED TO BE LOCAL INFLUX IN THE ANEURYSM AND IN THE GRAFT ON THE ECHO IMAGES, I SUSPECTED A TYPE 3B ENDOLEAK AS REPORTED BY THE DOCTOR.¿ AT THIS TIME ADDITIONAL TREATMENT IS UNDER CONSIDERATION BUT HAS NOT BEEN COMPLETED. 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. THE COMPLAINT OF TYPE III B ENDOLEAK IS CONFIRMED. ENDOLEAK RETURN INTO THE ENDOGRAFT DURING DIASTOLE WAS EVIDENCE THAT THE DEFECTED WAS UNUSUALLY LARGE FOR A TYPE III B ENDOLEAK. IF THE REPORTS ASSERTION THAT THE IMPLANTATION WAS WITHIN INDICATION, MEANING WITHIN THE IFU, THE CALCIFICATION ADJACENT THE DEFECT WAS LIKELY ORIGINALLY IN CONTACT WITH THE ENDOGRAFT AND MAY HAVE GENERATED THE DEFECT THROUGH FRICTION. 15MM OF INFRARENAL AORTA IS AVAILABLE TO EXTEND THE SEAL ZONE AND SIMULTANEOUSLY COVER THE FABRIC DEFECT WITH A MAINBODY EXTENSION. THIS LEFT RA WOULD BE COVERED BUT THE LEFT KIDNEY IS SEVERELY ATROPHIED. THE SHORT CIA SEAL ZONE LENGTH WAS LIKELY THE RESULT OF CIA DILATION AT THE ZSLE¿S INFERIOR EDGE. 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 6760553 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RELATED NON-CONFORMANCES. A DATABASE SEARCH WAS COMPLETED FOR THE COMPLAINT LOT AND NO OTHER LOT RELATED COMPLAINTS WERE FOUND. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE FAILURE ANALYSIS, DEVICE HISTORY RECORD, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING, SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE 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: 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. ¿ THE SAFETY AND EFFECTIVENESS OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE Z-TRAK INTRODUCTION SYSTEM HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: - LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSMS. 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. LENGTHS: ¿ 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, STENT FRACTURE OR BARB SEPARATION) 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 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: ¿ 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 6.5 ENDOLEAK MANAGEMENT DURING THE CLINICAL STUDY TYPE I ENDOLEAKS WERE TREATED DURING THE INITIAL PROCEDURE BY USE OF ADDITIONAL BALLOON SEATING OR IF UNSUCCESSFUL, ADDITIONAL PROSTHESES. 7 PATIENT SELECTION AND TREATMENT 8 PATIENT COUNSELING INFORMATION THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. 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 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. 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. BASED ON THE INFORMATION PROVIDED, EXPERT REVIEW OF MEDICAL IMAGING PROVIDED BY THE FACILITY, AND THE RESULTS OF OUR INVESTIGATION, COOK COULD NOT DETERMINE A DEFINITIVE CAUSE FOR THE FAILURE MODE; HOWEVER, PATIENT CONDITION/ANATOMY WAS A LIKELY CONTRIBUTING FACTOR. THE IMAGE REVIEWER NOTED ¿IF THE REPORTS ASSERTION THAT THE IMPLANTATION WAS WITHIN INDICATION, MEANING WITHIN THE IFU, THE CALCIFICATION ADJACENT THE DEFECT WAS LIKELY ORIGINALLY IN CONTACT WITH THE ENDOGRAFT AND MAY HAVE GENERATED THE DEFECT THROUGH FRICTION.¿ THE IFU STATES IN SECTION 4 WARNINGS AND PRECAUTIONS ¿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." 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.
E1: PHONE: (B)(6), POSTAL CODE: (B)(6). 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
AN UNKNOWN PATIENT, UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2016. TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PROCEDURE WAS REPORTED, TO BE WITHIN INDICATION. THE GRAFTS WERE NOT ALTERED PRIOR TO IMPLANT. THE FOLLOWING COOK DEVICES WERE PLACED IN THE PROCEDURE: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 6760553). PLACED IN THE ABDOMINAL AORTA, BELOW THE RENAL ARTERY. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT, LOT NUMBER 6993096). PLACED IN THE RIGHT COMMON ILIAC ARTERY. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT, LOT NUMBER: 6409808). PLACED IN THE LEFT COMMON ILIAC ARTERY. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) CONTRAST ENHANCED SCAN COMPLETED ON (B)(6) 2023 SHOWED ANEURYSM DIAMETER ENLARGEMENT IN THE ABDOMINAL REGION. ECHOCARDIOGRAPHY ALSO CONFIRMED, THAT THERE WAS AN AREA THAT APPEARED TO HAVE INFLUX INTO THE ANEURYSM, FROM A LOCALIZED LOCATION PERIPHERAL OF THE FIRST STENT IN THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. IT IS SUSPECTED, THAT THERE IS A TYPE III ENDOLEAK ON THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. AS CONTRAST WAS SEEN FROM THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY BIFURCATION TO THE CONTRALATERAL LIMB. ADDITIONAL TREATMENT FOR THE IDENTIFIED ENDOLEAK IS UNDER CONSIDERATION, BUT HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1321411 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 6760553 | 10827002484327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | ZENITH FLEX ILIAC LEG, ZSLE-20-74-ZT, LOT 6409808| ZENITH FLEX ILIAC LEG, ZSLE-20-74-ZT, LOT 6993096 |