MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Off-Label Use (1494)

Patient Problems Aortic Dissection (2491); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as zenith alpha thoracic.Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) year-old male patient underwent zone 1 debranching tevar with zenith alpha for saccular aneurysm in the distal site of the aortic arch.The patient had severe emphysema and under the home oxygen therapy.Endoleak (type unknown) was confirmed after the procedure.3 months later, additional tevar in the proximal site was performed with zenith alpha.((b)(4)).6 months later (3 months later than the additional tevar), rtad occurred.Diameter of the false lumen was 20mm, so open-chest surgery was planned.In consideration of endurance against the operation, the user did not expose the bypass graft at the cervical region but t-shaped partial sternotomy was performed at the second intercostal space, then ascending aorta replacement was conducted with blocking the blood flow.((b)(4)).Diameter of the proximal landing zone (diameter of the branch to the brachiocephalic artery) was 39.6mm and the diameter of the distal landing zone was 28.1mm.Diameter of the ascending aorta was 43.3mm.Zenith alpha 42-38-173 + 32-109 (not sure but probably zta-p-42-38-173-w1 + zta-p-32-109-w1) were used first, then zenith alpha 44-179 (not sure but probably zta-p-44-179-w1) was additionally placed.Proximal site marked 12%up.Entry was at the bare stent location along the inner curvature.Regarding rtad, proximal landing zone marked 10-14%up, but the proximal diameter of the used devices were 40-44mm which are big and also the diameter of the ascending aorta was enlarged at 38.8-43.3mm ((b)(4)).Patient outcome: unknown, but there have been no adverse effects reported.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: on the 48th annual meeting of japanese society for vascular surgery an abstract on a patient was presented.The patient was a 78-year-old male patient with a saccular aneurysm in the distal site of the aortic arch, it was reported that the patient had a diameter of the proximal landing zone was 39.6mm and the diameter of the distal landing zone was 28.1mm.Diameter of the ascending aorta was 43.3mm.The patient underwent debranching tevar and had two zenith alpha devices implanted, presumably a zta-p-42-38-173-w1 and a zta-p-32-109-w1.The proximal landing zone was zone 1.An unknown type endoleak was found after the procedure (pr 317825) and additional tevar was performed after 3 months where a zenith alpha (presumably a zta-p-44-179-w1) was placed at the proximal site.3 months after the second procedure the patient developed rtad and had to undergo open surgery (this complaint).It was described that the entry was at the bare stent location along the inner curvature.The instructions for use for this type of device states that the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer with a length of at least 20 mm.Based on the limited information available it has not been possible to establish an exact cause for this event.The proximal landing zone in this patient was proximal for zone 1, which is outside of intended use.It has not been possible to establish if this has contributed to the rtad.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: UNKNOWN
• 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: 11184211
• MDR Text Key: 231639611
• Report Number: 3002808486-2021-00026
• Device Sequence Number: 1
• Product Code: MIH
• 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: 07/13/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention