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-30-109-W1

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

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

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device marketed under p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: on 17february, postoperative ct scan was performed.When the ct was checked on the morning of 19february, there was evidence of a dissection-like entry in a part of the central bare stent of the alpha thoracic, and a thrombosed false lumen leading to the left subclavian artery occurred.(the diameter of the vessel near the left subclavian artery had not changed significantly before and after the surgery, so the false lumen may extend to the distal arch.) the diameter of the descending aorta was about 26 mm preoperatively, but it had expanded to about 36 mm postoperatively.The patient did not complaint about pains and other symptoms.If the physician had wanted to implant an additional stent graft in the proximal with good properties, it would have had to be extended to zone 2.However, the vessel diameter near the left subclavian artery was 40 mm, and the vessel wall might have be fragile, so the physician did not want to implant a thick stent graft, and the physician did not want to lengthen the treatment length too much due to the patient's advanced age, so the physician decided to place a zta-de-30-108-w1 (lot# e3941080) around the proximal bare stent of zta-p-30-109-w1 (lot# e3991670) where the entry existed.Patient outcome: since the false lumen was thrombosed, there was no false lumen blood flow from the entry from the beginning, but the treatment of the dissection was performed as intended in this case.The patient has recovered.However, due to the retrograde stanford type b dissection, the duration of hospital stays got extended.

Event Description

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

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a 89-year old male patient previously treated for aaa (abdominal aortic aneurysm) underwent thoracic endovascular repair (tevar) with a zta-de-30-108-w1 (lot number e3994877) and a zta-p-30-109-w1 (complaint device) due to tortuosity in the descending aorta, which became an aneurysm.On the 5 days follow-up ct an evidence of a dissection-like entry in the location of the bare stent of the zta-p-30-109-w1 and a thrombosed false lumen leading to the left subclavian artery (lsa) was revealed.The diameter of the descending aorta had expanded from 26mm to 36 mm postoperatively.The physician decided to implant a zta-de-30-108-w1 (lot number e3941080) around the proximal bare stent of the zta-p-30-109-w1 where the entry existed.Due to this occurrence the patient experienced a prolonged hospitalization.It was reported that the patient recovered.Preimplantation cta and cta five days post-implantation were provided and reviewed by an imaging expert.Per findings in the imaging review, on the pre-implantation cta, a distal thoracic pseudoaneurysm was just downstream an acute distal aortic bend.The report states that the lesion was considered an aneurysm.However, because the lesion penetrated the aortic intimal and at least partially penetrated the media, it was in the spectrum of penetrating ulcer/focal dissection.Since the resulting bulge did not consist of all aortic wall layers, it represented a pseudoaneurysm rather than a true aneurysm.Also, per findings in the imaging review, the bare stent was implanted in an ovoid segment of the descending thoracic aorta where the lumen was 23.4mm x 25.8mm.The aortic wall thickness at the eventual bare and sealing stent implantation site was normal thickness except for some very mild age appropriate atheromatous thickening and a small calcified plaque.The bare stent apex penetrated through the intima soon after implantation.The penetration site was towards the lung and along the short (23.4mm) axis of the aorta.At this location, external support from the lung was minimal and relative constraint of the bare stent maximal.Per the impressions in the imaging review, the original lesion, the two chronic dissections, and the new intimal tear indicate that despite a previously treated aaa, the thoracic aortic disease was primarily in the dissection rather than aneurysm spectrum.Moreover, the sine may not have been the sole cause of the dissection because a new more proximal, albeit significantly smaller, entry tear may have also had a role.Review of the device history record gave no indication of the device being manufactured out of specification.Per the ifu, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.Moreover, the ifu states, that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in patients with dissections.Based on the provided information and imaging review, it has not been possible to determine an exact cause of the reported event.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
• 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: 11371444
• MDR Text Key: 241428760
• Report Number: 3002808486-2021-00152
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449449
• UDI-Public: (01)10827002449449(17)230625(10)E3991670
• 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: 10/07/2021

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: 06/25/2023
• Device Catalogue Number: ZTA-P-30-109-W1
• Device Lot Number: E3991670
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR