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

Device Problems Loss of or Failure to Bond (1068); Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/03/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k) number: similar to device under pma/510(k) p140016.(b)(4).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 Description

Based on findings in the imaging review of (b)(4) manufacturer ref#3002808486-2022-00875.A bypass graft from the left common carotid artery to distal left subclavian artery (lsa) is patent.The proximal lsa is occluded but there is scan flow into the origin of the lsa, likely antegrade, representing a limited type 1a endoleak.

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).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: this complaint was open to address a limited type 1a endoleak based on the findings in the imaging review for (b)(4).No treatment was performed.A male patient with a thoracoabdominal aneurysm was treated with a zta-pt-46-42-233 (complaint device).The patient was previously treated with an aortic bifurcated prothesis.The zta was part of the staged procedure.The uncovered stent of zta was partly deployed in the brachiocephalic trunk (tabc).Per the reported information, the physician thinks that the uncovered stent of zta has dissected the tabc (b)(4).The dissection occurred within the lcca (left common carotid artery).The patient required an additional procedure due to this occurrence.No further information regarding the type of additional intervention was provided.No adverse effects on the patient due to this occurrence were reported.A preoperative and 5-week postop ct study are provided for review along with the complaint report and reviewed by an imaging expert.Per the findings in the imaging review ¿the patient has type 2 bovine arch anatomy with a common trunk for the innominate (brachiocephalic) artery and lcca.A bypass graft from the lcca to distal lsa is patent.The proximal lsa is occluded but there is scan flow into the origin of the lsa, likely antegrade.There is no contrast around the remainder of the proximal zta graft.¿ review of the device history record found no indication that the device was produced outside of specification.The proximal leak did not flow into the aneurysm sac and therefore is not an endoleak.Based on the provided information and imaging review it has not been possible to establish the cause of the leak.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 TAPERED 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: 15415827
• MDR Text Key: 299833244
• Report Number: 3002808486-2022-00952
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346618
• UDI-Public: (01)10827002346618(17)250208(10)E4218601
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-PT-46-42-233
• Device Lot Number: E4218601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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
• Patient Sex: Male