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

Model Number	G38191
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k): p140016.Investigation is still in progress.
Event or Problem Description
According to initial reporter: i did a case with a physician and our alpha thoracic device would not track due to the length of the nose cone being problematic, specifically in this patient¿s anatomy.It was the 2nd device that wouldn¿t track.Additional information received on 01jun2021: landed an alpha graft at the left subclavian artery.This 2nd piece would not track through the first graft due to the nose cone length combined with the patient's tortuous anatomy.Additional information received on 02jun2021: the first device mentioned in the initial e-mail was the other device involved in this procedure, and it had no problem.To clarify, only the second device did not track.Additional information received 03jun2021: the first device was implanted with no issue at the left subclavian artery.The 2nd device would not track through the first device due to the nose cone in combination with the patients anatomy.The ascending aorta was short, the arch was tight and the first stent being in place took away the ability to advance the device.Patient had 2cm seal zone distal to the left subclavian artery and then a large aneurysm immediately after.Plan was to seal proximally with a 40-167 (which we did successfully) and then place a series of tapered graft to end above the celiac artery.After the 2nd alpha would not track the physician implanted 2 gore ctags (40x15 and 40x20) to extend coverage to the descending thoracic aorta and then placed a zdeg-pt-42-34-160-pf-us (lot e3953764) landing above the celiac artery.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: alpha thoracic device would not track.The indication for the procedure was a thoracic aneurysm.The complaint device was the 2nd device (zta-pt-40-36-167-w) that wouldn¿t track through the first device due to the nose cone in combination with the patient¿s anatomy.The ascending aorta was short, the arch was tight and the first stent being in place took away the ability to advance the 2nd device.The first device (zta-p-40-167-w) was implanted with no issue at left subclavian artery.After the 2nd alpha would not track the physician implanted 2 gore ctags to extend coverage to the descending thoracic aorta and then placed a zdeg-pt-42-34-160-pf-us landing above the celiac artery.The patient was recovering well, and physician stated there were no complications post-op.Imaging review was performed by an imaging expert.Three angiographic images photographed from a monitor (during the procedure) were provided.From the imaging review relevant findings showed that a zta-p-40-167 was successfully implanted in an elongated aortic arch to exclude a descending thoracic aortic aneurysm.The aneurysm began 2 cm distal to the lsa origin.The planned distal seal zone was just proximal to the ca.The zta-pt tip contacted the outer curvature of the zta-p along the outer aortic curvature.The type iii arch and aneurysm combined to create a s-curved path that was accentuated by relatively shallow insertion of the guidewire.The guidewire may have been positioned in this manner to illustrate the course of the zta-pt.Deeper wire insertion may have straightened the path, but this would not have been enough to prevent contact and displacement of the zta-p-40-167.Per imagine reviewer¿s impression the complaint of inability to track the zta-pt-40-167 deep enough without displacing the more proximal zta-p-40-167 was confirmed.Also, the reviewer noted that because of the anatomy any device contacting the zta-p-40-167 on the outer aortic curvature would have displaced it.Review of device history record gave no indication of the device being produces outside of specifications.No evidence to suggest that the product was not manufactured according to specifications.According to the ifu careful evaluation of vessel size, anatomy, and disease state is required to ensure successful sheath introduction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or thrombus lined may preclude introduction of the endovascular graft and/ or increase the risk of embolization.The ifu also recommends not to 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 is difficult to establish an exact cause for this event based on the provided information and images(still images).But based on the imaging review the advancement difficulties was most likely due to patient anatomy where a type iii arch and aneurysm created a s-curved path.Cook will reopen the investigation if further information is received.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 or Problem 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
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11964316
• Report Number: 3002808486-2021-01302
• Device Sequence Number: 11839494
• Product Code: MIH
• UDI-Device Identifier: 10827002381916
• UDI-Public: (01)10827002381916(17)230923(10)E4020984
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: G38191
• Device Catalogue Number: ZTA-PT-40-36-167-W
• Device Lot Number: E4020984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1