ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2023-00061
- Event Type
- Malfunction
- Date Received
- March 14, 2023
- Date of Event
- June 6, 2019
- Report Date
- August 7, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346427
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(6). ADDITIONAL INFORMATION RECEIVED ON 17MAY2023 CONFIRMING THAT (B)(6) , MANUFACTURER REPORT# 3002808486-2023-00090 IS A DUPLICATE OF THIS COMPLAINT (B)(6) , MANUFACTURER REPORT# 3002808486-2023-00061. INFORMATION IS TRANSFERRED FROM (B)(6) , MANUFACTURER REPORT# 3002808486-2023-00090 TO (B)(6) , MANUFACTURER REPORT# 3002808486-2023-00061 AND GOING FORWARD ALL INFORMATION WILL BE HANDLED IN THIS COMPLAINT. INVESTIGATION IS STILL IN PROGRESS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
MANUFACTURERS REF# (B)(4). H6) ANNEX A: A050408 - ENDOLEAKS. SUMMARY OF INVESTIGATIONAL FINDINGS: A 74-YEAR-OLD FEMALE PATIENT UNDERWENT THORACIC ENDO VASCULAR AORTIC REPAIR (TEVAR) FOR TREATMENT OF AN AORTIC ANEURYSM. 03JUN2019, DURING THE INDEX PROCEDURE, A ZDEG-P-32-202-PF WAS IMPLANTED WITHOUT DIFFICULTY. THE PROCEDURE WAS DONE PERCUTANEOUSLY VIA RIGHT AND LEFT FEMORAL ACCESS SITE. A BALLOON WAS USED TO DILATE THE SUPERIOR MESENTERIC ARTERY TO BE ABLE TO PASS THROUGH. THE ZTA-PT-34-30-209 DEVICE (COMPLAINT DEVICE) WAS PLACED BELOW THE SUBCLAVIAN ARTERY AND THE ZDEG DEVICE WAS PLACED DISTALLY TO THE ZTA WITH PROXIMAL FIXATION INSIDE THE ZTA DEVICE. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND NO SEPARATION OF DEVICES. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE. NO SECONDARY INTERVENTION FOR THE TYPE IA PROXIMAL ENDOLEAK WAS PERFORMED AND NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE WERE REPORTED. ON (B)(6) 2020 (514 DAYS POST-PROCEDURE), A CT REVEALED A TYPE IIIA ENDOLEAK WITHIN THE ZDEG STUDY DEVICE AND THE GRAFT FROM ANOTHER MANUFACTURER AT THE RIGHT RENAL ARTERY ((B)(4)). THE TYPE IA PROXIMAL ENDOLEAK WAS NO LONGER PRESENT AT THE CT. A POST OPERATIVE CT STUDY 514 POST-PROCEDURE WAS PROVIDED AND REVIEWED BY AN IMAGING EXPERT. ACCORDING TO THE IMAGING REVIEW THE TYPE IA ENDOLEAK OBSERVED AT IMPLANTATION WAS NOT PRESENT ON THE IMAGES FROM (B)(6) 2020 (514 DAYS POST-PROCEDURE). FURTHERMORE, IT WAS NOTED THAT THE ZTA DEVICE WAS IMPLANTED IN A FROZEN ELEPHANT TRUNK GRAFT. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. IT IS NOTED THAT AS PER INSTRUCTIONS FOR USE (IFU), THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR INCLUDING NON-ANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC ANEURYSM WITH A LENGTH OF AT LEAST 20 MM. PER THE IFU THE SAFETY HAS NOT BEEN EVALUATED FOR PATIENTS WITH PREVIOUS REPAIRS IN THE DESCENDING THORACIC AORTA. BASED ON THE PROVIDED INFORMATION AND IMAGING REVIEW IT IS ASSESSED THAT THE CAUSE FOR THE EVENT IS LIKELY RELATED TO USE ERROR, AS THE DEVICE WAS PLACED IN AN ARTIFICIAL VESSEL. ENDOLEAK IS LISTED AS A POTENTIAL ADVERSE EVENTS IN THE IFU. IT IS NOTED THAT ZTA IS USED IN COMBINATION WITH ZDEG. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
MANUFACTURERS REF# (B)(4). DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO STUDY: TYPE IIIA-PROXIMAL ENDOLEAK REPORTED ON 29OCT2020 (B)(4). (B)(6) 2019 A ZDEG-P-32-202-PF (LOT# E3844931) WAS IMPLANTED WITHOUT DIFFICULTY. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE. PRIMARY INDICATION FOR IMPLANT WAS AORTIC ANEURYSM AND PRE-PROCEDURAL IMAGING INFORMATION WAS NOT PROVIDED AT THIS TIME. THE PROCEDURE WAS DONE PERCUTANEOUSLY VIA RIGHT AND LEFT FEMORAL ACCESS SITE. A BALLOON WAS USED TO DILATE THE SUPERIOR MESENTERIC ARTERY TO BE ABLE TO PASS THROUGH. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND NO SEPARATION OF DEVICES. PROCEDURAL ANGIOGRAPHY SHOWED A TYPE IA PROXIMAL ENDOLEAK AND REPORTED THIS ENDOLEAK WAS WITHIN THE ZTA DEVICE (B)(4). (B)(6) 2020 (514 DAYS POST-PROCEDURE) A COMPUTERIZED TOMOGRAPHY (CT) REVEALED A TYPE IIIA ENDOLEAK WITHIN THE ZDEG STUDY DEVICE AND THE GRAFT FROM ANOTHER MANUFACTURER AT THE RIGHT RENAL ARTERY. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON THE SAME DAY, THE PATIENT UNDERWENT STENT TO THE RIGHT RENAL ARTERY, ENDOVASCULARLY. THE DEVICES INVOLVED WAS THE ZDEG DEVICE, BUT AS AN ENDOLEAK TYPE IIIA, THE ENDOLEAK ALSO INVOLVED THE STENT AT THE RIGHT RENAL ARTERY. (B)(6) 2021 (759 DAYS POST PROCEDURE) A CT REVEALED TYPE IIIA ENDOLEAK OF THE ZDEG DEVICE WAS REPORTED. THE ZDEG DEVICE WAS PROXIMAL, AND THE DISTAL DEVICE INVOLVED WAS A GRAFT FROM ANOTHER MANUFACTURER. DEVICE IS PATENT AND NO DEVICE INTEGRITY ISSUES OR SEPARATION OF THE DEVICE HAVE BEEN REPORTED. NO DEVICE MIGRATION HAS OCCURRED. (B)(6) 2021 (862 DAYS POST PROCEDURE) A CT REVEALED TYPE IIIA ENDOLEAK OF THE ZDEG DEVICE WAS REPORTED. THE ZDEG DEVICE WAS PROXIMAL, AND THE DISTAL DEVICE INVOLVED WAS A GRAFT FROM ANOTHER MANUFACTURER. THE DEVICE IS PATENT AND NO DEVICE INTEGRITY ISSUES OR SEPARATION OF THE DEVICES HAVE BEEN REPORTED. NO DEVICE MIGRATION HAS OCCURRED. ADDITIONAL INFORMATION RECEIVED 08MAR2023: THE ZTA WAS ALSO IMPLANTED AS PART OF THE INDEX PROCEDURE FOR TREATMENT OF THE AORTIC ANEURYSM WITH THE ZDEG DEVICE ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED 09MAR2023: THERE HAVE NOT BEEN ANY ADDITIONAL INTERVENTION DONE TO TREAT THE TYPE IA ENDOLEAK. PATIENT OUTCOME: NO SECONDARY INTERVENTIONS RELATED TO DEVICE HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 914504 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3853438 | 10827002346427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Life Threatening |