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-34-112-W1

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

Patient Problems No Consequences Or Impact To Patient (2199); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device under p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a female patient underwent a repair of aneurysm in the distal aorta arch.Zta-pt-34-30-161-w1 (e4004073) was inserted from the right femoral and the stent graft was placed.Then the user inserted the delivery system of zta-de-34-112-w1 (e4045770) but it would not pass through the lumen of the previously placed stent graft (zta-pt-34-30-161-w1 - e4004073).The user decided not to try the different device and take wait-and-see approach and completed the procedure.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref#(b)(4).Summary of investigational findings: on (b)(6) 2021, a female patient underwent tevar with the indication ulcer and intramuralt hematoma.A zta-pt-34-30-161-w1 was inserted from the right femoral artery and the proximal end of the zta-pt device was placed right before the lcca, but covered lsa.Per the requested clarification the proximal seal zone length was 28mm and diameter 30mm, and calcification was observed in the proximal seal zone.After the stent graft was placed, proximal type 1 endoleak was confirmed ((b)(4)).According to the physician the possible cause for the endoleak was due to calcification in the proximal seal zone.To treat the proximal type 1 endoleak, the physician tried to insert zta-de-34-112-w1 (complaint device) but it would not pass through the lumen of the previously placed zta-pt device.Per the requested clarification the zta-de device was planned to land in zone 2 to cover the proximal endoleak.The physician decided not to try another device but take the wait-and-see approach and completed the procedure.No adverse effects on the patient was reported and the physician confirmed by follow up ct that the endoleak was gone.Review of the device history record found that all discovered non-conformances were properly dispositioned before release.The device was not returned, and no images was provided.A drawing representing the pre-procedure schema was provided and per the requested clarification the drawing shows calcification in the proximal landing/seal zone which most likely led to type 1a endoleak.The zta-de device was planned to land in zone 2 to treat the proximal endoleak.Based on the available information in this complaint it is not possible to establish an exact cause of the event but the instructions for use, shipped with this type of device, states: distal extensions can be used to provide additional length to the endovascular graft distally or to increase the length of overlap between components.Additional proximal components may be used to extend graft coverage proximally.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 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 DISTAL EXTENSIONS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11371194
• MDR Text Key: 244171889
• Report Number: 3002808486-2021-00149
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449180
• UDI-Public: (01)10827002449180(17)231202(10)E4045770
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: ZTA-DE-34-112-W1
• Device Lot Number: E4045770
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1