MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-DE-38-91-W1

Device Problems Off-Label Use (1494); Failure to Advance (2524)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

Description of event according to initial reporter: this case was within anatomical indications.Zta-pt-36-32-209-w1 (e4179753) was deployed in the arch aorta.Since type 1a endoleak was admitted, the user attempted to add zta-de-38-91-w1 (e4338064), however it could not pass through zta-pt.In the end, no additional treatment was performed, and the patient was to be observed.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Received by manufacturer 13sep2023 and assessed not reportable however investigation findings change assessment to reportable 07dec2023 g4) similar to device under pma/510(k) p140016 summary of investigational findings: a patient underwent thoracic endovascular aortic repair (tevar) to treat aortic aneurysm.A zta-pt-36-32-209-w1 was implanted in the aortic arch just distal to the brachiocephalic trunk (related complaint).It is reported that the patient had tortuous anatomy but was still inside patient selection criteria in the instruction for use.After deployment of zta-pt-36-32-209-w1 a type 1a endoleak was detected.The user then attempted to add a distal extension zta-de-38-91-w1 (complaint device) proximal to the already deployed stent graft to resolve the endoleak.It was however not possible to advance the distal extension through the proximal stent graft.The procedure ended with no additional treatment performed, and the patient was to be observed.Zta-de-38-91-w1 (complaint device) has been returned and device evaluation has been performed.The dilator tip and the tip of the sheath was inspected and no nonconformances were found.No indentations or damages were observed on the sheath or other parts of the device.It was not possible to establish the cause of inability to advance the device through the zta-pt based on the device evaluation.Review of the device history record found that all discovered non-conformances were properly dispositioned before release and no indication that the device was produced outside of specification.The instruction for use states "additional proximal main body components may be used to extend graft coverage proximally.Distal extensions are used to extend the distal body of an in situ endovascular graft" and "the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta".In this case the intention was to insert a distal extension (complaint device) in the aortic arch, proximal to an already inserted stent graft thus the use of complaint device is considered outside the ifu.Upon review of provided information it¿s not possible to determine an exact cause for the issues regarding advancement of complaint device.It cannot be ruled out that the intended placement of the complaint device in the aortic arch and the reported tortuous anatomy has made advancement through the zta-pt difficult.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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18324288
• MDR Text Key: 330480374
• Report Number: 3002808486-2023-00299
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449227
• UDI-Public: (01)10827002449227(17)251205(10)E4338064
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

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 Catalogue Number: ZTA-DE-38-91-W1
• Device Lot Number: E4338064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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