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-36-113

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event: protocol 13-005, pt.(b)(6), type 1a endoleak on zta-p-36-113, seen on 2 y fu.The patient was diagnosed with thoracic aortic aneurysm (taa) and that was the primary tevar indication.The patient had no symptoms and was categorized as an asa class 3 patient.Ct performed prior to study procedure revealed.The proximal neck diameter was 30 mm and the proximal neck length was 20 mm.Aneurysm maximum diameter was 55 mm.On (b)(6) 2017, during the index procedure, the patient received these cook devices: lot# e3594074 catalog# zta-p-36-113  proximal component.Lot# e3605725 catalog# zta-p-40-167  proximal component.The site indicated that delivery and deployment procedure was successful.The left subclavian artery (lsa) was intentionally completely covered by the stent graft fabric.The proximal zone of stent graft implantation was zone 2.The site performed an additional procedure of lsa occlusion by plug during the procedure.No reportable adverse events observed during the implant procedure.No endoleaks was left uncorrected.No evidence of false lumen perfusion.No evidence-collapse of proximal component.No additional technical observation.1-month fu: on (b)(6) 2017 (55 days post-procedure) the patient had a 1 month follow up ct scan performed.It revealed a maximum aneurysm diameter of 58 mm.A total length of covered aorta 192 mm.No technical observations/imaging abnormalities was observed on this imaging exam.2-year fu: on (b)(6) 2019 (662 days post-procedure) the patient had a 2 year follow up ct scan performed.The maximum aneurysm diameter was 54 mm and the total length of covered aorta 192 mm.The ct revealed a type 1a endoleak and the site indicated the location with following comment: proximal endoleak between left carotide artery and sub claviere artery.The site clarified in a query response that the endoleak type 1a was located on the zta-p-36-113 device.No evidence of stent graft migration.No evidence of collapse of the proximal component.No other technical observations/imaging abnormalities was observed on this imaging exam.Uns 1.On (b)(6) 2019 (666 days post-procedure) the patient had an event of an aneurysm.The event was not treated, and the site indicated that this was no sae (serious adverse event) with the following explanation: a secondary intervention should be necessary but the patients refused and is fragile.The site indicated that this event was not related to either study device or study procedure.Patient outcome: the patient remains in the study.

Manufacturer Narrative

Manufacturer ref# (b)(4).Complaint will be closed-cancelled as the complaint is a duplicate of a previously registered complaint handled in (b)(4), manufacturer report #3002808486-2019-00828.Patient code: 3191 - no code available for endoleak.E2402 - appropriate term / code not available 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11249326
• MDR Text Key: 232859826
• Report Number: 3002808486-2021-00064
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346984
• UDI-Public: (01)10827002346984(17)200613(10)E3594074
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: ZTA-P-36-113
• Device Lot Number: E3594074
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 100