MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA 2 THORACIC PROXIMAL COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G59926
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Corrected data compared with medwatch/medsun report #(b)(4).D3: cook medical incorporated, bloomington, in d6b: (b)(6) 2025 e1: last name: (b)(6).No serious injury or death has been reported.There is no evidence that the device malfunctioned nor caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the use of the device which would be required to prevent permanent impairment or damage to the patient.No alleged malfunction has been reported.The event is therefore considered as not reportable under fda 21 cfr part 803 as the event does not involve death, serious injury, or a device malfunction.William cook europe have previously informed fda of the occurrence and associated capa in relation to res 97615 (see attached summary).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 or Problem Description
Description of event according to cook representative and medsun (b)(4): they implanted the device and then realized minutes later that the device was the subject of a voluntary recall.The procedure was successfully completed with the device in question.From medsun report received 16jan2026: surgeon was provided (from cook medical sales rep) the zenith alpha 2 thoracic endovascular graft to place inside the patient.Surgeon was later notified from the sales rep that the device implanted was voluntarily recalled on [redacted]-68 days ago- due to the potential of scrapings of ptfe [polytetrafluoroethylene] coating from the ptfe coated nitinol release wire inside the graft may be released during the deployment.Patient outcome: the procedure was successfully completed with the device in question.No adverse effect due to the product reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).H10) updated to include medsun report reference number.The event is still considered as not reportable under fda 21 cfr part 803 as the event does not involve death, serious injury, or a device malfunction.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 24113687
• Report Number: 3002808486-2026-00009
• Device Sequence Number: 17614943
• Product Code: MIH
• UDI-Device Identifier: 00827002599260
• UDI-Public: (01)00827002599260(17)280319(10)E4677112
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: G59926
• Device Catalogue Number: ZTA2-P-42-121-W
• Device Lot Number: E4677112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 60 KG