ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
Report
- Report Number
- 3002808486-2016-00135
- Event Type
- Injury
- Date Received
- March 22, 2016
- Date of Event
- March 3, 2016
- Report Date
- July 4, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- PMA / PMN Number
- P140016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI). 400 DANIELS WAY. BLOOMINGTON, IN 47404. REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THE NEW INFORMATION STATES ANEURYSM GROWTH ((B)(6) 2016 & ((B)(6) 2016) AND THE SITE SUSPECTS THE CAUSE TO BE POROUS MATERIAL, EVEN THOUGH NO TYPE IV ENDOLEAK CAN BE DETECTED. ON (B)(6) 2016 A SECONDARY INTERVENTION WAS PERFORMED AND ZTEG-2P-34-152-PF WAS USED TO RELINE THE EXISTING GRAFT. ONLY THE DISTAL END OF THE FIRST STENT GRAFT REMAINED IDENTIFIABLE. ON THE FOLLOW-UP ON (B)(6) 2016 AND (B)(6) 2017 (5 YEARS), THE ANEURYSM DIAMETER WAS REPORTED TO 75 MM AND 72 MM, RESPECTIVELY. THE PREVIOUSLY PERFORMED INVESTIGATION DID NOT DETERMINE THE CAUSE OF THE REPORTED ANEURYSM GROWTH. TYPE IA ENDOLEAK WAS NOT IMAGED BUT WAS SUGGESTED AS A POSSIBLE CAUSE DUE TO PROXIMAL SEAL ZONE EXPANSION. THE REVIEW OF THE NEW IMAGING SHOWS ANEURYSM LENGTH STABILITY THROUGH FIVE YEARS. SINCE TYPE IA ENDOLEAKS TYPICALLY EXPAND AND SHORTEN THE PROXIMAL SEAL ZONE, WHILE LENGTHENING THE ANEURYSM, THIS ELIMINATES THE POSSIBILITY OF A TYPE IA ENDOLEAK. HOWEVER, THE REVIEW STATES THAT THE ANEURYSM GROWTH, WHICH WAS OBSERVED ON THE CTA PERFORMED ON (B)(6) 2016 (BEFORE THE SECONDARY PROCEDURE) REVEALED A TINY ENDOLEAK, POSSIBLY A TYPE III PIN HOLE ENDOLEAK. THE ENDOLEAK WAS OBSERVED IN A NARROW PORTION OF THE SAC WITH ADJACENT DENSE ATHEROMATOUS CALCIFICATION AND STENT STRUTS THAT PRODUCED STREAK ARTIFACT. CONTINUED CT SURVEILLANCE WILL DETERMINE THE CAUSE OF ANEURYSM GROWTH. IF GROWTH CONTINUES, THE CAUSE MAY LIKELY BE DUE TO SAC ONCOTIC PRESSURE, WHEREAS IF THE SAC STABILIZES OR SHRINKS, THE CAUSE LIKELY WAS A TYPE IIIB FABRIC HOLE ENDOLEAK. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). H6) PATIENT CODE: 1708 - ANEURYSM. DEVICE CODE: 1354 - LEAK. INVESTIGATION IS STILL IN PROGRESS 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. H3 OTHER TEXT : EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(6). REGISTRATION NO.: (B)(4). H6) PATIENT CODE: 1708 - ANEURYSM. DEVICE CODE: 1354 - LEAK. INVESTIGATION IS STILL IN PROGRESS. 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.
ADDITIONAL INFORMATION RECEIVED 27MAR2018: CT: (B)(6) 2016. ANALYSIS: ANEURYSM DIAMETER 72 MM; SITE = 71 MM. DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. SITE REPORTED ¿PROBABLY POROUS MATERIAL EVEN THOUGH NO ENDOLEAK TYP IV CAN BE DETECTED¿. CT: (B)(6) 2016. ANALYSIS: ANEURYSM DIAMETER 73 MM; SITE = 71 MM. DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. SITE REPORTED ¿PERSISTENT ENDOLEAK TYP IV WITH ANEURYSM PROGRESS (NONE VISIBLE ENDOTENSION)¿. SECONDARY INTERVENTION (B)(6) 2016: DUE TO ANEURYSM GROWTH, SITE¿S ASSESSMENT OF REASON FOR GROWTH: ¿IN OUR OPINION PROBABLY POROUS STENTGRAFT MATERIAL LEAD TO AN ENDOLEAK TYPE IV AND THEREFORE TO AN ANEURYSM GROWTH.¿ TREATMENT INVOLVED PERCUTANEOUS ¿TRANSFEMORAL ENDOLINING TEVAR VIA ZTEG-2P-34-152-PF¿. CT: (B)(6) 2016: ANALYSIS: ANEURYSM DIAMETER 75 MM ; SITE = 75 MM. DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. A NON-STUDY SECOND DEVICE WAS PLACED ENTIRELY WITHIN THE ORIGINAL EXISTING DEVICE. THE NEW DEVICE ALMOST COMPLETELY OVERLAPS THE ORIGINAL DEVICE, BUT THE DISTAL ENDS OF THE STUDY DEVICE REMAIN IDENTIFIABLE. THE NEW DEVICE COULD AFFECT FIRST CIRCUMFERENTIAL VISUALIZATION OF THE DEVICE BOTH AT THE PROXIMAL AND AT THE DISTAL ENDS. 5 YEAR: (B)(6) 2017. ANALYSIS: ANEURYSM DIAMETER 72 MM; SITE = 70 MM. DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. PATIENT OUTCOME: PATIENT COMPLETED THE 5-YEAR FOLLOW-UP AND HAS EXITED THE STUDY.
ADDITIONAL INFORMATION RECEIVED (B)(6)2018: CT: (B)(6) 2016: ANALYSIS: ANEURYSM DIAMETER 72 MM ; SITE = 71 MM DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. SITE REPORTED ¿PROBABLY POROUS MATERIAL EVEN THOUGH NO ENDOLEAK TYP IV CAN BE DETECTED¿ CT: (B)(6) 2016: ANALYSIS: ANEURYSM DIAMETER 73 MM ; SITE = 71 MM DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. SITE REPORTED ¿PERSISTENT ENDOLEAK TYP IV WITH ANEURYSM PROGRESS (NONE VISIBLE ENDOTENSION)¿ SECONDARY INTERVENTION (B)(6)2016: DUE TO ANEURYSM GROWTH, SITE¿S ASSESSMENT OF REASON FOR GROWTH: ¿IN OUR OPINION PROBABLY POROUS STENTGRAFT MATERIAL LEAD TO AN ENDOLEAK TYPE IV AND THEREFORE TO AN ANEURYSM GROWTH.¿ TREATMENT INVOLVED PERCUTANEOUS ¿TRANSFEMORAL ENDOLINING TEVAR VIA ZTEG-2P-34-152-PF¿ CT: (B)(6)2016: ANALYSIS: ANEURYSM DIAMETER 75 MM ; SITE = 75 MM DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. A NON-STUDY SECOND DEVICE WAS PLACED ENTIRELY WITHIN THE ORIGINAL EXISTING DEVICE. THE NEW DEVICE ALMOST COMPLETELY OVERLAPS THE ORIGINAL DEVICE, BUT THE DISTAL ENDS OF THE STUDY DEVICE REMAIN IDENTIFIABLE. THE NEW DEVICE COULD AFFECT FIRST CIRCUMFERENTIAL VISUALIZATION OF THE DEVICE BOTH AT THE PROXIMAL AND AT THE DISTAL ENDS. 5 YEAR: (B)(6)2017: ANALYSIS: ANEURYSM DIAMETER 72 MM; SITE = 70 MM DEVICE PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. PATIENT OUTCOME: PT COMPLETED THE 5-YEAR FOLLOW-UP AND HAS EXITED THE STUDY.
(B)(4). INVESTIGATION IS STILL IN PROGRESS. (B)(4). DEVICE IS SIMILAR AS DEVICE WITH 510(K) P140016.
(B)(4). DEVICE IS SIMILAR AS DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION WAS BASED ON DESCRIPTION OF EVENT AND IMAGING REVIEW. IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT HOWEVER IT IS UNLIKELY THAT ANEURYSM GROWTH WAS CAUSED BY TYPE IV ENDOLEAK. MOST LIKELY GROWTH WAS CAUSED BY TYPE IA ENDOLEAK NOT IMAGED. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: A (B)(6) MALE PATIENT WAS NOTED BY THE SITE ON THE 4 YEAR CT TO HAVE PROGRESSION OF THE THORACIC ANEURYSM. AT THE TIME OF THE INDEX PROCEDURE ON (B)(6) 2012, A PROXIMAL COMPONENT (ZTLP-P-34-161-CI) WAS IMPLANTED WITHOUT DIFFICULTY. NO ADDITIONAL COMPONENTS WERE PLACED AND NO ADDITIONAL PROCEDURES WERE DONE. THE COMPLETION ANGIOGRAM SHOWED THAT THE DEVICE WAS PATENT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2016: THE SITE DETECTED ANEURYSM PROGRESSION (7 CM) WITHOUT ANY ENDOLEAK OR GRAFT MIGRATION IN THE CT SCAN. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED
DESCRIPTION OF EVENT ACCORDING TO STUDY: A (B)(6) MALE PATIENT WAS NOTED BY THE SITE ON THE 4 YEAR CT TO HAVE PROGRESSION OF THE THORACIC ANEURYSM. AT THE TIME OF THE INDEX PROCEDURE ON (B)(6) 2012, A PROXIMAL COMPONENT (ZTLP-P-34-161-CI) WAS IMPLANTED WITHOUT DIFFICULTY. NO ADDITIONAL COMPONENTS WERE PLACED AND NO ADDITIONAL PROCEDURES WERE DONE. THE COMPLETION ANGIOGRAM SHOWED THAT THE DEVICE WAS PATENT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2016: THE SITE DETECTED ANEURYSM PROGRESSION (7 CM) WITHOUT ANY ENDOLEAK OR GRAFT MIGRATION IN THE CT SCAN. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173670 | ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Life Threatening| R |