ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2022-00303
- Event Type
- Injury
- Date Received
- February 24, 2022
- Date of Event
- August 6, 2021
- Report Date
- May 16, 2022
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552378
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CUSTOMER (PERSON): STREET: (B)(6) THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
INVESTIGATION ¿ EVALUATION: (B)(6) MEDICAL CENTER INFORMED COOK ON (B)(6) 2022 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT) LOT 697144. THIS COMPLAINT INVOLVES STUDY PATIENT (B)(6) ENROLLED IN THE ZENITH® P-BRANCH® PIVOTAL STUDY (B)(6). THE DEVICE REPORTEDLY HAD A TYPE 3A ENDOLEAK. ON (B)(6) 2016 THE PATIENT RECEIVED THE FOLLOWING DEVICES: PBRANCH-30-22 LOT AC944005X, UNIBDOY-24-81 LOT 927441, AND A ZSLE-16-74-ZT LOT 6991245 IN THE LEFT ILIAC LEG. ON (B)(6) 2021 A FIVE-YEAR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. THE DEVICES WERE PATENT WITH NO SEPARATION OF COMPONENTS, EVIDENCE OF MIGRATION DEVICE INTEGRITY ISSUES, OR ENDOLEAK, ON THE SAME DAY THERE WAS A NEW FINDING ON THE CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY), IT WAS NOTED ¿THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM CONTINUES TO INCREASE IN SIZE AND IS NOW AT 4 CM¿. ON (B)(6) 2022 THE PATIENT UNDERWENT SECONDARY INTERVENTION. COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM AND EXTENSION OF RIGHT COMMON ILIAC LIMB WITH A ZSLE-11-90. INITIALLY THERE WAS A TYPE 3A ENDOLEAK AT THE JUNCTION BETWEEN THE ZSLE-11-90 AND THE ZSLE-16-56. THIS WAS RESOLVED WITH BALLOON ANGIOPLASTY. THIS REPORT FOCUSES ON THE COMPLAINT FOR THE RIGHT INTERNAL ILIAC ANEURYSM GROWTH AND TYPE 3A ENDOLEAK OF THE ZSLE-16-56 LOT 6971477. THE TYPE 3A ENDOLEAK OF THE ZSLE-11-90 HAS BEEN CAPTURED IN MDR 1820334-2022-00304. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, SPECIFICATIONS, AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; HOWEVER, IMAGING WAS PROVIDED AND REVIEWED BY DR. PAUL E. TIMPERMAN, MD. THE IMAGE REVIEWER STATED, ¿THE COMPLAINT OF A TYPE IIIA ENDOLEAK BETWEEN THE RIGHT ZISL-16-56-ZT AND THE ZSLE-11-90-ZT EXTENSION CANNOT BE CONFIRMED AS IMAGING OF THE EVENT WAS NOT PROVIDED. BASED ON THE COMPLAINT REPORT DESCRIPTION, THE EVENT WAS A NORMAL INTRAPROCEDURAL PHENOMENA ELIMINATED WITH BALLOON MOLDING.¿ IT WAS ALSO STATED THAT, "THE COMPLAINT OF RIGHT IIA ANEURYSM GROWTH IS CONFIRMED. THIS ANEURYSM WAS DOWNSTREAM AND THEREFORE INDEPENDENT OF THE ZSLE-16-56-ZT. IIA ANEURYSM GROWTH WAS RELATED TO INTRINSIC ANEURYSMAL DISEASE. BILATERAL CIA DILATION AND RIGHT IIA ANEURYSM GROWTH INDICATE SEVERE ANEURYSMAL DISEASE INDEPENDENT OF THE INTENDED TO TREAT AAA. 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 AND RELATED SUB-ASSEMBLY LOTS REVEALED NO NONCONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_ZAAASZ_REV4 ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRACK 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. ¿ 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. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING ¿ 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 ENLATGEMENT: - 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. 11 DIRECTIONS FOR USE: 11.1 ZENITH SPIRAL-Z AAA ILIAC LEG SYSTEM 11.1.7 MOLDING BALLOON INSERTION 5. EXPAND THE MOLDING BALLOON WITH DILUTED CONTRAST MEDIA (AS DIRECTED BY THE MANUFACTURER) IN THE AREA OF THE MOST PROXIMAL COVERED STENT AND THE INFRARENAL NECK, STARTING PROXIMALLY AND WORKING IN THE DISTAL DIRECTION. 6. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL LIMB OVERLAP REGION AND EXPAND. 7. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL DISTAL FIXATION SITE AND EXPAND. 8. DEFLATE AND REMOVE MOLDING BALLOON. TRANSFER MOLDING BALLOON ONTO THE CONTRALATERAL WIRE GUIDE AND INTO THE CONTRALATERAL ILIAC LEG INTRODUCTION SYSTEM. ADVANCE MOLDING BALLOON TO THE CONTRALATERAL LIMB OVERLAP AND EXPAND. 9. WITHDRAW THE MOLDING BALLOON TO THE CONTRALATERAL ILIAC LEG/VESSEL DISTAL FIXATION SITE AND EXPAND. 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. 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. 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. BASED ON THE AVAILABLE INFORMATION, IMAGING REVIEW, AND THE RESULTS OF THE INVESTIGATION, COOK HAS DETERMINED THE TYPE 3 ENDOLEAK WAS A RESULT OF THE PROCEDURE, AS IT WAS RESOLVED WITH BALLOON ANGIOPLASTY DURING THE PROCEDURE. COOK HAS DETERMINED THE COMPLAINT OF ANEURYSM GROWTH IS UNRELATED TO THE DEVICE. AS THE IMAGE REVIEWER STATED, ¿RIGHT IIA (INTERNAL ILIAC ARTERY) ANEURYSM ENLARGEMENT WAS ACCOMPANIED BY DISTAL RIGHT CIA DILATION GREATER THAN 16MM. ALTHOUGH THE DILATION PERMITTED PERFUSION AROUND SEALING STENT, THE MID AND PROXIMAL LEFT CIA REMAINED SEALED AROUND THE ZSLE-16-56-ZT. BECAUSE THIS PERFUSION DID NOT COMMUNICATE WITH THE AAA, SAC IT WAS NOT AN ENDOLEAK. RIGHT ILIAC LEG EXTENSION INTO THE EIA (EXTERNAL ILIAC ARTERY) ALSO EXCLUDED THIS DILATED SEGMENT OF RIGHT CIA FROM THE CIRCULATION.¿ THE REVIEWER ALSO STATED ¿THE COMPLAINT OF RIGHT IIA (INTERNAL ILIAC ARTERY) ANEURYSM GROWTH IS CONFIRMED. THIS ANEURYSM WAS DOWNSTREAM AND THEREFORE INDEPENDENT OF THE ZSLE-16-56-ZT. IIA (INTERNAL ILIAC ARTERY) ANEURYSM GROWTH WAS RELATED TO INTRINSIC ANEURYSMAL DISEASE. BILATERAL CIA (COMMON ILIAC ARTERY) DILATION AND RIGHT IIA ANEURYSM GROWTH INDICATE SEVERE ANEURYSMAL DISEASE INDEPENDENT OF THE INTENDED TO TREAT AAA.¿ 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.
AT THE TIME OF ENROLLMENT, PRE-PROCEDURE IMAGING CONDUCTED BY THE SITE NOTED A STABLE ABDOMINAL AORTIC ANEURYSM WITH VISCERAL ARTERY INVOLVEMENT. THE PROXIMAL SEALING ZONE SHOWED NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE BILATERAL COMMON ILIAC ARTERIES. THERE WAS MILD CALCIFICATION AND NO OCCLUSIVE DISEASE OF THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE LEFT EXTERNAL ILIAC ARTERY. THERE WAS MODERATE TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. CORE LAB ANALYSIS NOTED AN ANEURYSM DIAMETER OF 48.90 MM. THE PROXIMAL SEALING ZONE WAS PARALLEL SHAPED AND SHOWED MILD CALCIFICATION AND NO OCCLUSIVE DISEASE OR THROMBUS. THERE WAS MILD CALCIFICATION OF THE BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. THERE WAS NO OCCLUSIVE DISEASE OF THE BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. THERE WAS MODERATE TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR. DURING THE PROCEDURE, THE FOLLOWING COOK DEVICES WERE IMPLANTED: ZENITH P-BRANCH ENDOVASCULAR GRAFT (RPN: PBRANCH-30-22-A LOT NUMBER AC944005X) ZENITH UNIVERSAL DISTAL BODY ENDOVASCULAR GRAFT (RPN: UNIBODY-24-81 LOT NUMBER REPORTED AS "927441") ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 6971477) PLACED IN THE RIGHT COMMON ILIAC ARTERY ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT, LOT 6991245) PLACED IN THE LEFT COMMON ILIAC ARTERY THE PATIENT ALSO RECEIVED NON-COOK COVERED STENTS IN THE SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY, AND LEFT RENAL ARTERY. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE DEVICES WERE PATENT WITH NO DEVICE INTEGRITY ISSUES OR ENDOLEAK. CORE LAB ASSESSMENT OF THE COMPLETION ANGIOGRAM CONCURRED WITH THE SITE ASSESSMENT. ON (B)(6) 2021 (1863 DAYS POST-PROCEDURE), THE FIVE-YEAR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) WAS COMPLETED AND REVEALED THE MAXIMUM ANEURYSM DIAMETER WAS 39.0 MM. THE DEVICES WERE PATENT WITH NO SEPARATION OF COMPONENTS, EVIDENCE OF MIGRATION, DEVICE INTEGRITY ISSUES, OR ENDOLEAK. CORE LAB ANALYSIS REVEALED THE MAXIMUM ANEURYSM DIAMETER WAS 34.0 MM. THE DEVICES WERE PATENT AND THERE WAS NO SEPARATION OF COMPONENTS, EVIDENCE OF MIGRATION, DEVICE INTEGRITY ISSUES, OR ENDOLEAK. ON THE SAME DAY (06AUG2021), THE PATIENT¿S PRE-EXISTING RIGHT INTERNAL ILIAC ANEURYSM HAD A NEW FINDING ON THE COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN (CTA). THE INVESTIGATOR NOTED, ¿RIGHT INTERNAL ILIAC ARTERY ANEURYSM CONTINUES TO INCREASE IN SIZE AND IS NOW AT 4 CM. THE PATIENT WILL REQUIRE EMBOLIZATION. ON (B)(6) 2022 (2028 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A SUCCESSFUL SECONDARY INTERVENTION. THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM WAS COIL EMBOLIZED. AN EXTENSION GRAFT (ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN: ZSLE-11-90-ZT WAS PLACED IN THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC ARTERY. THE SITE INVESTIGATOR STATED ¿FOLLOW-UP CT SCANS HAVE DEMONSTRATED ANEURYSMAL DEGERMATION OF THE RIGHT DISTAL COMMON ILIAC AND INTERNAL ILIAC ARTERIES.¿ THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM WAS FOUND TO BE 5 MM AT THE TIME OF THE SECONDARY INTERVENTION. INITIALLY WITH TYPE 3 ENDOLEAK AT JUNCTURE OF THE PRIOR LIMB AND NEW EXTENSION WHICH RESOLVED WITH 14 MM BALLOON ANGIOPLASTY (DATE UNKNOWN). THE PATIENT WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2022, THE PATIENT COMPLETED AND EXITED THE STUDY. THIS REPORT REFERENCES RIGHT INTERNAL ILIAC ANEURYSM GROWTH AND A TYPE 3A ENDOLEAK IDENTIFIED WITH THE ZSLE-16-56-ZT. THE TYPE 3A ENDOLEAK IDENTIFIED WITH ZSLE-11-90-ZT HAS BEEN CAPTURED ON ANOTHER REPORT WITH PATIENT IDENTIFIER:(B)(6).
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 |
|---|---|---|---|---|---|---|---|
| 225858 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 6971477 | 10827002552378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention | ATRIUM 6 MM X 22 MM , LOT 228690005.| ATRIUM 6 MM X 22 MM, SN (B)(6).| ATRIUM 7 MM X 22 MM, SN (B)(6).| COOK RPN: UNIBODY-24-81 LOT 927441.| COOK RPN: ZSLE-16-74-ZT LOT 6991245.| COOK RPN:PBRANCH-30-22-A, LOT AC944005X. |