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

Model Number	G35341
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# pr (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: successful case and outcome.Patient returned a week later with infected aorta.He was questioned to have infection before the case, but unconfirmed.Patient outcome: the patient is scheduled for an endograft explant of the device on the (b)(6) 2021.The patient had an enlarged aneurism, high white count.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: this complaint is related to (b)(4) (manufacturer ref#3002808486-2021-01937) 69-year-old male patient received a tevar (thoracic endovascular aortic repair) for a descending thoracic aortic aneurysm.Two devices were used, zta-p-30-109-w (e4125427, complaint device)) and zta-p-30-109-w (e4016600, complaint device).The operation was successful with no difficulties experienced but a week later the patient returned with infected aorta.It was questioned if the patient had an infection before the operation but it was unconfirmed.Patient was scheduled for an explant surgery on (b)(6) 2021, and it is noticed that the issue has been resolved.Imaging review has been performed by cri on 15oct2021 and was based on one preoperative ct.Relevant findings and impressions: there is aneurysmal dilation of the mid descending ta to maximum diameter of 41 x 38 mm.There is a focal area of mild stranding or adventitial thickening at the distal sac on the left posterolateral aspect.No other remarkable abnormalities are seen around the aorta.In retrospect, this stranding could be a sign of an indolent aortic infection prior to implantation but is non-specific and very subtle.The scan is otherwise unremarkable for signs of a pre-existing infection.The cause of the reported aortic infection cannot be determined from the imaging and information provided.Most likely causes are an indolent underlying infection at the time of repair resulting in bacteremia, contamination of devices/instruments at the time of implantation, or a postoperative infection resulting in bacteremia.Review of device history record gave no indication of the device being produced outside of specifications.Per ifu infection in the endovascular graft is a known potential adverse event.Conclusively, possible explanations could be pre-existing infection, contamination of device/instrument, or postoperative infection but it is not possible to determine the exact cause to the infected stent graft.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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12538756
• Report Number: 3002808486-2021-01835
• Device Sequence Number: 4079686
• Product Code: MIH
• UDI-Device Identifier: 10827002353418
• UDI-Public: (01)10827002353418(17)240621(10)E4125427
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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?: No
• Device Expiration Date: 06/21/2024
• Device Model Number: G35341
• Device Catalogue Number: ZTA-P-30-109-W
• Device Lot Number: E4125427
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male