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

Catalog Number ZTA-D-38-197-W1

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref#: (b)(4).Complaint was received 11sep2023 and at first considered not reportable, however investigation completed 19dec2023 concluded that the complications due to difficulties during introduction was more serious than assumed at first intake and is therefore now considered reportable as a serious injury.G4) similar to device under pma: p140016.Summary of investigational findings: the zta-d-38-197-w1 (complaint device) was delivered after zta-p-38-217 implantation from zone 4, but it was not able to pass through the zta-p (current complaint).The zta-d-38-197-w1 was removed because of the need for wire guide replacement and was re-delivered when the through and through technique was ready.Zta-d-38-197-w1 was deployed as usual just above the sma (superior mesenteric artery), but the distal bare stent was not released due to difficulties with bottom cap removal.Eventually, the troubleshooting was performed, and distal bare stent was successfully released (related complaint).No adverse effect on the patient has been reported.The physician wondered if the slightly twisted delivery system during delivery had something to do with difficulty in releasing distal bare stent.Per the reported information, there was a relatively strong bend in the descending aorta, but the area just above the sma was straight and did not interfere with deployment operations.This complaint regards difficulty in advancement of zta-d through zta-p.Review of the device history record gave no indication of the device being produced out of specification.No imaging was provided, and no device was returned.Based on the provided information it has not been possible to establish an exact cause for the difficult advancement of the complaint device through the previously implanted zta-p device.However, the reported tortuous anatomy in the descending aorta could have contributed to the reported event.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 Description

Description of event according to initial reporter.Patient anatomy before surgery: there was no problem with access route.(there is a relatively strong bend in the descending aorta.) no bend in the area directly above the sma (superior mesenteric artery) where zta-d-38-197-w1 was implanted.After implanting zta-p-38-217-w1 from zone 4, zta-d-38-197-w1 was deployed as usual just above the sma, but the distal bare stent was not released.Eventually, the troubleshooting procedures were followed and distal bare stent was successfully released.Additional information received 13jun2023: when he delivered zta-d-38-197-w1, the first one, zta-p-38-217, interfered and could not be delivered, so he switched to a through and through guidewire technique and delivered it, and that he thought the delivery system was slightly twisted during delivery (the inner and outer sheaths may have been twisted).The doctor wondered if the slightly twisted delivery system during delivery had something to do with difficulty in releasing distal bare stent.Additional information received 11sep2023: the zta-d was delivered after zta-p implantation, but it was not able to pass through the zta-p.The zta-d was removed because of the need for wire guide replacement, and was re-delivered when the through and through technique was ready.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18434395
• MDR Text Key: 331867520
• Report Number: 3002808486-2024-00002
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448879
• UDI-Public: (01)10827002448879(17)231126(10)E4045360
• 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
• Report Date: 01/03/2024

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: 11/26/2023
• Device Catalogue Number: ZTA-D-38-197-W1
• Device Lot Number: E4045360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2020
• 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): Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female