MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-P-46-125-W1

Device Problems Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under pma/510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the patient underwent the placement of 2 stent grafts produced by another manufacturer in 2018: valiant44-40-150 was for the proximal site, and valiant42-18-150 was for the distal site.The ct was performed due to the suspicion of aaa.However, endoleak type 1b was observed at the site 17mm above the superior mesenteric artery/the distal site of the stent graft.There is a possibility of the migration of the stent graft (valiant), and the migration caused endoleak type 1b.Then, the physician decided to give priority to taa over aaa and to place an additional thoracic stent graft.On (b)(6) 2019, zta-p-42-121-w1 was placed although the condition of the access routes from both the right and the left were bad, and there was extreme tortuosity in the anatomy.In the angiography after the additional treatment, it was observed that endoleak type 1b did not disappear because it might have not been enough for overlapping.Therefore, the complaint zta-p-46-125-w1 was prepared and attempted to be advanced from the left.However, the delivery system could not be advanced.Also, the tip of the delivery system became frayed, so the user decided to remove it from the body considering the risk of vascular injury.Consequently, zta-de-46-97-w1 prepared as a spare was placed instead of the complaint device to complete the procedure.Endoleak type 1b finally disappeared.The diameter of the vessel for the complaint device was 35mm.There were resistance both in the access vessel and in the aorta.Introduction system stopped advancing around the left cia.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a 72 year old female patient was treated for aaa in 2018 using 2 stent-grafts from another manufacturer.During a follow-up angiography (b)(6) 2019 a type 1b endoleak was discovered 17 mm above the superior mesenteric artery/at the distal site of the stent graft.The physician decided to treat the endoleak by placing an additional thoracic stent graft (zta-p-42-121-w1).However, the angiography after this additional treatment revealed that the endoleak did not disappear.Therefore, the complaint device zta-p-46-125-w1 was prepared and an attempt was made to advance it, but it could not be advanced further than the left common iliac artery.Furthermore, the dilator tip became frayed, so it was decided to replace the complaint device with a zta-de-46-97-w1.The procedure was completed and the endoleak disappeared.The patient had bad access routes, and there was extreme tortuosity in the anatomy.The vessel diameter at the target site for the complaint device was 35 mm.No adverse effects to the patient was reported.No product was returned and no imaging was provided.No information on the access vessel diameters was provided.The vessel diameter at the target site was reported to be 35 mm.The use of zta-p-46-125-w1 is not in accordance to the sizing guidelines stated in the ifu, but since the device did not reach the target site, this is not relevant for this complaint.Regarding the advancement difficulty the ifu states: do not continue advancing the wire guide or any portion of the introduction system if resistance is felt.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.There is no evidence to suggest the device was not manufactured to specification.An exact cause of the event cannot be determined based on the provided information.However, it is likely that the bad access routes and the extreme tortuosity in the anatomy contributed to the advancement difficulty.Cook will reopen the complaint if further information is received.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.

Event Description

Clarification of description of event received (b)(6) 2019: it was the dilator-tip that became frayed.Patient outcome: the patient has not experienced any adverse effects.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8738362
• MDR Text Key: 159419689
• Report Number: 3002808486-2019-00821
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449760
• UDI-Public: (01)10827002449760(17)210131(10)E3682937
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: ZTA-P-46-125-W1
• Device Lot Number: E3682937
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 16 MO
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR