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-36-161-W1

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: on (b)(6) 2021: a male patient with widespread taa underwent tevar for impending rupture repair emergently.There was no landing zone since the aorta arch to the thoracic descending aorta had become aneurysmal, so total arch replacement by open-heart surgery was conducted first.The physician planned placing zta-p-36-161-w1 in the proximal side first and then placing zta-d-40-197-w1 in the distal side.He inserted the delivery system of the zta-p-36-161-w1 but it would not advance to the target area although the access vessel had no problem.He then felt something wrong about the position of the sheath tip and the dilator in the fluoroscopic images.The tip of the delivery system looked being bent fluoroscopically.So he removed the delivery system from the patient once and found the tip of the delivery system was bent and only the dilator was advanced more than normal.It caused a gap between the dilator and the sheath tip, so he stop using it and replaced it with zta-p-36-209-w1.This replacement could advance to the target area with no problem and the stent graft was placed.The rest of the procedure was completed with no problem.Patient outcome: the patient did not experience any adverse affects due to this occurrence.

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: it is reported that, on (b)(6) 2021 a male patient with widespread thoracic aortic aneurysm (taa) underwent emergency thoracic endovascular aortic repair (tevar) for an impending rupture.There was no landing zone since the aorta arch to the thoracic descending aorta had become aneurysmal, so total arch replacement by open-heart surgery was conducted first.The physician planned placing a zta-p-36-161-w1 (complaint device) in the proximal side first and then a zta-d-40-197-w1 distally.He inserted the delivery system of the zta-p-36-161-w1 but it would not advance to the target area although the access vessel reportedly had no problem.He then felt something wrong about the position of the sheath tip and the dilator in the fluoroscopic images.The tip of the delivery system looked bent under fluoroscopy.The customer removed the delivery system from the patient and found the tip of the delivery system was bent and the dilator was advanced more than normal.It caused a gap between the dilator and the sheath tip.The customer stopped using the device and replaced it with a zta-p-36-209-w1.This replacement could advance to the target area and the stent graft was placed.The rest of the procedure was completed with no problem.It is reported that the patient did not experience any adverse effects due to this occurrence.As per additional information received it is provided that the location of the advancement difficulty was in the previously implanted artificial vessel ¿ elephant trunk.The cook representative present for the procedure has commented that the sheath of the delivery system probably got caught in the artificial vessel and it caused pushing of the dilator.No product was returned for the investigation.One photograph was provided.Based on evaluation of the photo it was not possible to determine a cause for the advancement difficulties.In relation to the current issue, cook reviewed the device master record for this type of device, and it was assessed that there are adequate controls in place to ensure the device was manufactured to specifications.A review of the device history record for the device and relevant subassemblies was performed for the investigation.It is concluded that there are no indications that the device was produced outside of specifications.In relation to the current event, cook conducted a review of the current version of the instructions for use (i-alpha-thoracic-443-04) which states: ¿do not continue advancing the wire guide or any portion of the introduction system if resistance is felt.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.¿ it was further noted that the indication for the procedure was impending rupture of the aorta.As per ifu, the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in patient populations with leaking, pending rupture or ruptured aneurysm.It is possible that interaction with the artificial vessel caused the inability to advance the device through the artificial vessel.However, based on the provided information the conclusion for the complaint is cause not established.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: 11264200
• MDR Text Key: 244171128
• Report Number: 3002808486-2021-00080
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449586
• UDI-Public: (01)10827002449586(17)230708(10)E3996100
• 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: 04/21/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Catalogue Number: ZTA-P-36-161-W1
• Device Lot Number: E3996100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1