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

Catalog Number ZTA-PT-46-42-233-W1

Device Problem Device Tipped Over (2589)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a male patient underwent taa repair.The taa was located in the thoracic descending aorta near the aorta arch.The access vessel was poor with calcification.The delivery system of zta-pt-46-42-233-w1 was inserted from the left side and the stent graft was placed right below the left sabclabian artery.However the proximal neck of the stent graft was bent in the lesser curvature due to the proform-tie.The customer fixed it using a balloon catheter.He placed zta-d-44-211-w1 in the distal side and the procedure was completed.Patient outcome: the patient did not experience any adverse effects dut to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: (b)(6) 2021 a male patient underwent taa repair.The taa was located in the thoracic descending aorta near the aorta arch.The access vessel was poor with calcification.The delivery system of zta-pt-46-42-233-w1 was inserted from the left side and the stent graft was placed right below the left subclavian artery.However, after placing the zta-pt the proximal neck of the stent graft was bent in the lesser curvature.The physician straighten out the stent graft using a balloon catheter.The physician then placed a zta-d-44-211-w1 in the distal side and the procedure was completed.No adverse effect on the patient was reported.Two still images of an angiography during procedure and 3mensio planning images from a ct and the sizing sheet were provided and reviewed by an imaging expert.The imaging expert confirms the event in this complaint based on the provided images.Per the findings of the imaging review ¿the arch was an elongated type iii arch.¿ and ¿although the intended to treat aneurysm was in the mid distal thoracic aorta, the neck of a more proximal aneurysm, as indicated by abnormal aortic wall thickening on the inner aortic curvature and aortic expansion, began at zone 2.¿ based on these findings the imaging reviewers¿ impressions are ¿the angulation was potentiated by the type iii arch, endograft implantation in a proximal thoracic aortic aneurysm rather than at the lsa, and possibly inferior traction on the unsheathed endograft prior to trigger wire release.The delivery system typically lies asymmetrically along the outer aortic curvature in a type iii arch.The aneurysm would have accentuated this.The aneurysm and asymmetry provided room for the inner curvature side of the bare and sealing stents to expand first towards the inner aortic curvature.This also may have been aggravated by inferior traction on the unsheathed mainbody prior to release.The flared and unusually conspicuous outer curvature sealing stent barbs are evidence of this.¿ it has not been possible to establish an exact cause of the event but based on the imaging review patient anatomy could have contributed to the proximal sealing and bare stent angled towards the inner aortic curvature.Cook will reopen the investigation if further information is received.There are adequate controls in place to ensure the device was manufactured to specifications.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: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 11371645
• MDR Text Key: 233282189
• Report Number: 3002808486-2021-00153
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448756
• UDI-Public: (01)10827002448756(17)230930(10)E4024303
• 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: 07/06/2021

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: 09/30/2023
• Device Catalogue Number: ZTA-PT-46-42-233-W1
• Device Lot Number: E4024303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1