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-36-209-W
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.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.
Event or Problem Description
Description of event according to initial reporter: "upon deployment of the device, it was moving backwards and then upon surgeon manipulating it jumped forward and encroached on the arch vessels (innominate & left common carotid artery)lcca)).The left subclavian artery (lsa) was planned for coverage as a lcca-lsa bypass was done prior.Upon an angio the lcca had a fair amount of coverage that required stenting to ensure the vessel remains open.Final result of the case was as planned with no endoleak and all vessels preserved.No preexisting conditions or comorbidities present.".
Event or Problem Description
Additional information 10apr2024: did the product cause or contribute to the need for additional procedures? yes, stented the left common carotid in the same procedure.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: upon deployment of the zta-p-36-209-w (complaint device), it was moving backwards and then upon surgeon manipulating it jumped forward and encroached on the arch vessels (innominate artery and lcca (left common carotid artery).The lsa (left subclavian artery) was planned for coverage as a lcca-lsa bypass was done prior.Upon an angiography the lcca had a fair amount of coverage that required stenting to ensure the vessel remains open.Final result of the case was as planned with no endoleak and all vessels preserved.Lcca was stented in the same procedure.No preexisting conditions or comorbidities present.As reported, the physician did not experience any difficulties with advancement of the device.A preoperative ct (computed tomography) study was provided and reviewed by an imaging expert.Per the imaging review "this is a type 2 arch with broad appearance and relatively flat central segment at the arch vessel origins.The roc (radius of curvature) is 28 to 29 mm.A type 2 aortic dissection begins at the lsa origin and appears thrombosed at the proximal segment of the false lumen.Perfusion of the false lumen begins about 49 mm distal to the lsa where a small entry tear is seen.The dissection continues through the descending ta with dual lumen perfusion and terminates just below the celiac origin with full re-expansion of the true lumen at the level of the sma.The proximal neck diameter is 33 mm at the lcca, 33 mm at the lsa (10 mm from lcca), and then dilates to 36 x 38 mm at 20 mm below the lcca including the false lumen.The true lumen diameter here is 31 to 32 mm.The maximum ta diameter is 41 mm at the proximal to mid segment".Per the impressions in the imaging review "there are no concerning anatomic findings with the aortic arch on the preop imaging.The complaint is most likely due to operator technique during deployment, specifically regarding appropriate forward pressure during deployment to prevent distal migration, and then excessive subsequent forward pressure during deployment to try to advance the device proximally again, resulting in the device suddenly jumping forward".Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information and imaging review, it is likely that forward pressure during deployment contributed to the stent graft was implanted more proximal than expected and partially covered the lcca.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
• Common Device Name: 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 19018944
• Report Number: 3002808486-2024-00059
• Device Sequence Number: 12804987
• Product Code: MIH
• UDI-Device Identifier: 10827002353562
• UDI-Public: (01)10827002353562(17)260327(10)E4388068
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 03/27/2026
• Device Catalogue Number: ZTA-P-36-209-W
• Device Lot Number: E4388068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female