ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2019-00513
- Event Type
- Death
- Date Received
- February 25, 2019
- Date of Event
- December 10, 2018
- Report Date
- July 1, 2019
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002484327
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
CONCOMITANT MEDICAL PRODUCTS: TWO (2) - 46 CODA BALLOONS. THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF THE INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE AND IMAGING OF THE EVENT WAS NOT RETURNED; THEREFORE, NO PHYSICAL OR VISUAL EXAMINATIONS COULD BE PERFORMED. IN THE ABSENCE OF THE DEVICE AND IMAGING, A SIMILAR COMPLAINT (B)(4) WAS REFERENCED AND FOUND THAT INFORMATION PROVIDED FOR THIS INVESTIGATION SUGGEST THAT THIS WAS AN EMERGENCY PROCEDURE DUE TO THE PATIENT PRE-EXISTING CONDITION OF AORTIC RUPTURE AND THERE WAS NO PROCEDURAL PLANNING. THE IFU PROVIDED FOR THE DEVICE STATES, "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". WITHOUT PLANNING INFORMATION OR IMAGING OF THE EVENT, IT CANNOT BE DETERMINED IF THE PATIENT'S ANATOMY WAS WITHIN IFU INDICATION FOR REPAIR WITH THE TFFB-36-95-ZT. ADDITIONALLY, IT CANNOT BE DETERMINED IF THE TFFB-36-95-ZT WAS APPROPRIATELY SIZED FOR THE PATIENT'S VESSELS. A TYPE 1A ENDOLEAK WOULD HAVE RESULTED FROM INCOMPLETE SEALING OF THE TFFB GRAFT WITHIN THE PROXIMAL NECK REGION. THIS CAN BE CAUSED BY IMPROPER SIZING OF THE TFFB GRAFT OR THE ANATOMY OF THE NECK REGION. IFU INDICATIONS FOR USE SPECIFY THAT THE DEVICE IS INDICATED FOR USE WITH PATIENTS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR INCLUDING A "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 M AND NO LESS THAN 18 MM, WITH AN ANGLE <60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND WITH AN ANGLE <45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA." WITH THE INFORMATION PROVIDED FOR THIS INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MANUFACTURED OUT OF SPECIFICATION. THE TYPE 1A ENDOLEAK WAS NOT RESOLVED WITH PLACEMENT OF A MAINBODY EXTENSION (ESBE-36-73-ZT, LOT: 8251853) OR A PALMAZ STENT GRAFT. THE ESBE WAS PLACED ABOVE PROXIMAL EDGE OF THE TFFB GRAFT TO ELONGATE THE SEAL ZONE WITHIN THE NECK REGION. THE PALMAZ STENT IS A BARE METAL STENT WAS PLACED TO INCREASE THE RADIAL FORCE OF THE PREVIOUSLY PLACED TFFB AND ESBE GRAFTS. THE PERSISTENCE OF THE TYPE 1A ENDOLEAK DESPITE THE ADDITIONAL GRAFT PLACEMENT SUGGESTS THAT THE 36MM SEALING STENTS OF THE TFFB AND ESBE WERE UNABLE TO CONFORM AND SEAL WITH THE ANEURYSM NECK DESPITE INCREASED RADIAL FORCE FROM THE PALMAZ STENT. THIS INDICATES THAT THE ENDOLEAK IS LIKELY A RESULT OF IMPROPER DEVICE SELECTION OR IRREGULAR NECK ANATOMY. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DESIGN VERIFICATION TESTING PERFORMED SHOWED THAT THE AFFECTED PRODUCT MEETS THE ESTABLISHED ACCEPTANCE CRITERION FOR BENCH DEPLOYMENT, COMPONENT SEPARATION, PULSATILE FATIGUE TESTING, ABRASION TESTING, PROFILE/DIAMETER TESTING, AND DIMENSIONAL VERIFICATION TESTING. A REVIEW OF THE DEVICE HISTORY SHOWED ZERO NONCONFORMANCES FOR MAIN LOT 9307465 AND SUBASSEMBLY LOT SA8140215. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR LOT 9307465. THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING 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: SECTION 2: INDICATIONS FOR USE: "THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE WITH THE Z-TRAK INTRODUCTION SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS, 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 M AND NO LESS THAN 18 MM, WITH AN ANGLE <60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND WITH AN ANGLE <45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA." SECTION 4: WARNINGS AND PRECAUTIONS: "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); 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." "INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA." "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: TRAUMATIC AORTIC INJURY. LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSMS. MYCOTIC ANEURYSMS. UNCORRECTABLE COAGULOPATHY. INDISPENSABLE MESENTERIC ARTERY. PATIENTS WITH LESS THAN 15 MM IN LENGTH OR GREATER THAN 60 DEGREES ANGULATION OF THE PROXIMAL AORTIC NECK RELATIVE TO THE LONG AXIS OF THE ANEURYSM." "PRE-PROCEDURE IMAGING RECONSTRUCTION THICKNESSES >3 MM MAY RESULT IN SUB-OPTIMAL DEVICE SIZING, OR IN FAILURE TO APPRECIATE FOCAL STENOSIS FROM CT. " "STRICT ADHERENCE TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT 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." "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." POTENTIAL ADVERSE EVENTS: DEATH. EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION 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 NEUROLOGIC LOCAL OR SYSTEMIC COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., STROKE, TRANSIENT ISCHEMIC ATTACH, PARAPLEGIA, PARAPARESIS, PARALYSIS) SURGICAL CONVERSION TO OPEN REPAIR." "INSPECT THE DEVICE AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPPING. DO NOT USE THIS DEVICE IF DAMAGE HAS OCCURRED OR IF THE STERILIZATION BARRIER HAS BEEN DAMAGED OR BROKEN. IF DAMAGE HAS OCCURRED, DO NOT USE THE PRODUCT AND RETURN TO COOK." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE, BUT RATHER TO AN ADVERSE EVENT RELATED TO THE PATIENT CONDITION. THE COMPLAINT DEVICE WAS IMPLANTED IN AN EMERGENCY EVAR PROCEDURE TO TREAT A RUPTURED AAA. THIS INDICATED THAT THE NECESSARY PRE-IMPLANTATION IMAGING RECOMMENDED IN THE PRODUCT INSTRUCTIONS FOR USE WAS LIKELY NOT USED TO APPROPRIATELY SIZE THE DEVICE. ADDITIONALLY THE PRODUCT INSTRUCTIONS FOR USE STATES, ¿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.¿ WITHOUT IMAGING OR PLANNING INFORMATION, IT CANNOT BET DETERMINED IF THE TFFB WAS APPROPRIATELY SIZED TO THE ANEURYSM NECK REGION OR IT THE PATIENT¿S ANATOMY WAS WITHIN THE INSTRUCTIONS FOR USE INDICATIONS FOR ENDOVASCULAR REPAIR. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND 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.
THE PATIENT'S PRE-EXISTING CONDITION WAS AN AORTIC RUPTURE. THERE WAS A BIT OF ILIAC CALCIFICATION. TWO 46 CODA BALLOONS WERE ALSO USED DURING THE PROCEDURE IN THE PROXIMAL SEAL, AS WELL AS THE PREVIOUSLY REPORTED DEVICES. AN AUTOPSY REPORT WILL NOT BE PROVIDED AND A DEATH CERTIFICATE IS NOT AVAILABLE. THE CAUSE OF DEATH DETERMINED BY THE PHYSICIAN WAS BOWEL ISCHEMIA AND HEMODYNAMIC SHOCK. IT WAS REPORTED THAT THE PATIENT DEATH WAS POTENTIALLY PATIENT RELATED. THE EXPLANTED DEVICE IS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. IMAGING WILL NOT BE PROVIDED FOR THE INVESTIGATION.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
CONCOMITANT MEDICAL PRODUCTS: ZSLE-20-74-ZT, LOT# 7940570 - LEFT ILIAC. ZSLE-13-74-ZT, LOT# 7232046 - LEFT ILIAC. ZSLE-20-56-ZT, LOT# 6371301 - RIGHT ILIAC. ESBE-36-73-ZT, LOT# 8251853 - AORTA. ZSLE-16-74-ZT, LOT# 7659759 - RIGHT ILIAC. PALMAZ STENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THE (B)(6) MALE PATIENT, UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR ON (B)(6) 2018. AS REPORTED, THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DID NOT COMPLETELY SEAL PROXIMALLY AND A TYPE IA ENDOLEAK WAS VISIBLE DURING THE FINAL ANGIOGRAM. THEY ATTEMPTED TO RESOLVE THE ENDOLEAK BY DEPLOYING A CUFF TO EXTEND THE SEAL HOWEVER A TYPE IA ENDOLEAK WAS STILL VISIBLE. THEN A STENT FROM ANOTHER MANUFACTURER WAS DEPLOYED TO RESOLVE THE ENDOLEAK BUT THIS WAS ALSO UNSUCCESSFUL. FINALLY, THE DECISION WAS MADE TO CONVERT TO OPEN SURGICAL REPAIR AND ALL GRAFTS WERE EXPLANTED. THE AORTA WALL WAS VERY WEAK SO IT TOOK LONGER THAN EXPECTED TO SEW IN A GRAFT. WHILE THEY SEWED IN A NEW GRAFT FROM ANOTHER MANUFACTURER THE PATIENT¿S BOWEL BECAME ISCHEMIC. THE PHYSICIANS COMPLETED A BOWEL RESECTION. THE PATIENT PASSED AWAY ON (B)(6) 2018. AT THE TIME OF THIS REPORT, THE CAUSE OF DEATH IS UNKNOWN. ADDITIONAL INFORMATION REGARDING THE ISCHEMIA, PROCEDURE, AND PATIENT INFORMATION WERE REQUESTED BUT HAVE NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160800 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G48432 | 9307465 | 10827002484327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Death| R |