MAUDE Adverse Event Report: William Cook Europe Zenith Alpha 2 Thoracic Proximal Component; MIH System, Endovascular Graft, Aortic Aneurysm Treatment

Model Number	G60023
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: the bare stent did not land parallel in the aorta.They ballooned it because of the tortuosity of the stent.The patient had chest pain.There was a focal dissection in that area so there was a second stent placed successfully although there is still a small leak.Images are available.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.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.

• Brand Name: Zenith Alpha 2 Thoracic Proximal Component
• Common Device Name: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
• Manufacturer (Section D): William Cook Europe; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): William Cook Europe; sandet 6; bjaeverskov DK463 2; DA DK4632
• Manufacturer Contact: henriette christiansen ; sandet 6; bjaeverskov DK463-2 ; DA DK4632 ; +045()56868382
• MDR Report Key: 50172509
• Report Number: 3002808486-2026-00148
• Device Sequence Number: 9886730
• Product Code: MIH
• UDI-Device Identifier: 00827002600232
• UDI-Public: (01)00827002600232(17)280922(10)E4754512
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

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
• Operator of Device: Health Professional
• Device Model Number: G60023
• Device Catalogue Number: ZTA2-P-36-209-W
• Device Lot Number: E4754512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown