ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2023-01178
- Event Type
- Injury
- Date Received
- August 31, 2023
- Date of Event
- August 18, 2023
- Report Date
- October 16, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552378
- 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 WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-56-ZT) LOT 4715582. 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. THIS COMPLAINT WILL FOCUS ON THE TYPE 3A ENDOLEAK OF THE ZSLE-16-56-ZT LEG GRAFT. MDR #1820334-2023-01179 CAPTURES THE LOSS OF SEAL (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 4715582 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_ZAAASZ_REV3 ¿ZENITH SPIRAL-Z AAA ILIAC LEG 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 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. ¿ 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 ¿ 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) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. 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 ENHANCED 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 PRECLUDED 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. 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 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 ¿ AORTIC DAMAGE, INCLUDING PERFORATION, DISSECTION, BLEEDING, RUPTURE AND DEATH ¿ 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 8 PATIENT COUNSELING INFORMATION ¿ 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 ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE 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. 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 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. 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. 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 3A ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT LOT NUMBER 4715582) THAT WAS DISCOVERED DURING THE REINTERVENTION PROCEDURE AND REQUIRED RELINING. AN ADDITIONAL REPORT WITH THE PATIENT IDENTIFIER 406759 WILL BE SUBMITTED FOR THE TYPE 1A AND TYPE 3B ENDOLEAK ON THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT, LOT NUMBER 4053084).
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 |
|---|---|---|---|---|---|---|---|
| 1602483 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 4715582 | 10827002552378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | COOK RPN:TFFB-36-95-ZT, LOT 4053084.| COOK RPN:ZBIS-10-45-41 LOT A937127.| COOK RPN:ZSLE-20-56-ZT LOT 4792180. |