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-40-217-W1

Device Problems Material Separation (1562); Malposition of Device (2616)

Event Date 02/02/2023

Event Type  Injury  

Event Description

Description of event according to initial reporter: emergent tevar was performed for a patient who had y-graft replacement for the abdominal aorta before.The physician placed zta-p-34-209-w1 in the descending aorta first and placed zta-p-40-217-w1 in the aorta arch.Then he confirmed proximal type i endoleak.He advanced the delivery system of zta-de-42-94-w1 to treat the endoleak, but the delivery system would not pass the previously placed zta-p-40-217-w1 (e4016306) in the aorta arch.He then replaced it with pre-curved zta-p-40-167-w1 but it would not pass the same area either.So he performed extra ballooning using gore's tri-lobe balloon instead of placing additional stent graft and confirmed the endoleak was gone.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: emergent tevar was performed to treat a thoracic aortic aneurysm for a patient who had y-graft replacement for the abdominal aorta before.The physician placed zta-p-34-209-w1 in the descending aorta first and placed zta-p-40-217-w1 (complaint device) in the aorta arch.Then a proximal type i endoleak was confirmed.The physician advanced the delivery system of zta-de-42-94-w1 ((b)(4)) to treat the endoleak, but the delivery system would not pass the previously placed zta-p-40-217-w1 in the aorta arch.It was then replaced with a pre-curved zta-p-40-167-w1 but it would not pass the same area either ((b)(4)) the physician performed extra ballooning using balloon (device from another manufacturer) instead of placing additional stent graft and confirmed the endoleak was gone.Per additional information received it is reported that the left subclavian artery (lsa) was covered and proximal landing zone was between left common carotid artery (lcca) and left subclavian artery (lsa) with a seal zone length of 25 mm and a diameter of 35 mm.According to the physician the suspected cause for the endoleak was enfolding/pleatings due to oversizing of the stent graft.No adverse effects to the patient are reported.Review of the device history record gave no indication of the device being produced out of specification.Planning sizing sheet or imaging were not provided.According to the physician he suspect the endoleak to be caused by enfolding/pleatings due to oversizing, but this is not confirmed on images.It is reported that the diameter of the proximal seal zone was 35 mm and the complaint device had a diameter of 40 mm, this sizing is inside the ifu.Based on the provided information it has not been possible to establish a cause for the endoleak.Cook will reopen the investigation if further information or images are received.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.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.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.

Event Description

Additional information received 17feb2023: cause of endoleak: enfolding.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16331172
• MDR Text Key: 309130952
• Report Number: 3002808486-2023-00043
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449678
• UDI-Public: (01)10827002449678(17)230910(10)E4016306
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

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: 09/10/2023
• Device Catalogue Number: ZTA-P-40-217-W1
• Device Lot Number: E4016306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 02/28/2023
• Supplement Dates FDA Received: 02/20/2023; 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention