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-28-155-W1

Device Problems Off-Label Use (1494); Malposition of Device (2616)

Event Date 04/02/2024

Event Type  malfunction  

Event Description

Description of event according to initial reporter: on 30 march at 4:00 am, patient was underwent emergency tevar for thoracic descending aortic rupture (maximum diameter approximately 70 mm) approached from the right fa (pr426404).The procedure was within the applicable range.The products below were placed, and the final contrast showed no endoleak within the aneurysm, and the procedure was completed.- zta-p-28-201-w1/e4496599 - zta-p-28-155-w1/e4491030 - zta-de-30-108-w1/e4512304 -esbe-28-80-t-pf-d/e4245725 esbe was implanted under procedure to correct type 1b endoleak related to zta-p-28-155-w1/e4491030.Esbe-28-80-pf-d was additionally placed on the distal side, and the procedure was completed when the doctor determined that blood flow into the aneurysm was no longer confirmed by contrast imaging.

Manufacturer Narrative

Manufacturer ref (b)(4) blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma/510(k) p140016 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

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).Summary of investigational findings: on (b)(6) 2024, a female patient underwent an emergency thoracic endovascular repair (tevar) for thoracic descending aortic rupture (maximum diameter approximately 70 mm) approached from the right femoral artery.The exact place of the rupture was unknown, but it is reported likely around the thoracic vertebrae 9-10 (th9-10) and the descending aorta was aneurysmal along its entire length.There was a history of total arch replacement (tar) surgery on the proximal side with an elephant trunk beyond the distal arch.It is described the following devices were implanted: zta-p-28-201-w1, lot e4496599 (complaint device), zta-p-28-155-w1, zta-de-30-108-w1, and esbe-28-80-t-pf-d.The zta-p-28-155-w1 was placed first, just above the celiac.The zta-p-28-201-w1 was then deployed within the elephant trunk, with 2 stents placed over the elephant trunk.1 stent overlaps the zta-p-28-155-w1 device.The zta-de-30-108-w1 was then placed in the junction of the two zta devices.Due to a type 1b endoleak from zta-p-28-155-w1 an esbe was implanted distally, just above the celiac.The final contrast showed no endoleak within the aneurysm, and the procedure was completed.On (b)(6) 2024, the patient developed bradycardia and subsequently died.After death, ct scan revealed a large amount of bleeding into the thoracic cavity, and death was thought to be due to re-rupture of the aortic aneurysm, unclear exactly where it ruptured.The postmortem ct showed that the stent graft was sealed.Per additional information, it is noted that ¿the physician's finding was that the entire thoracic cavity was hemorrhaging, and it was unclear exactly where it ruptured, but it was probably around the above area¿ (presumed around th9-10).It is therefore assumed that the re-rupture is around the zta-p-28-201-w1.This complaint addresses the type 1b endoleak during the procedure.According to the instruction for use (ifu) the zta is a two-piece cylindrical endovascular graft consisting of proximal and distal components.The proximal component can be either tapered or non-tapered and may be used independently (for ulcers/saccular aneurysms) or in combination with a distal component.It is noted that the complaint device is used in combination with an esbe device.The safety and effectiveness for this combination have not been evaluated.Also, it is noted that the zta is used for treatment of a ruptured aneurysm.Per ifu the safety and effectiveness of the zta have not been evaluated in patients with ruptured aneurysms.Furthermore, endoleaks are a known adverse event associated with tevar procedures.Review of the device history record gave no indication of the device being produced out of specification.No imaging or sizing has been provided for investigation.Based on the limited information it has not been possible to determine the exact cause for the type 1b endoleak.Cook will reopen the investigation if further information or images are received.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
• 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): COOK MEDICAL; sandet 6, dk-4632; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: alex rahbek ; sandet 6, dk-4632; bjaeverskov DK-46-32 ; DA DK-4632 ; 30632506
• MDR Report Key: 19141378
• MDR Text Key: 340698344
• Report Number: 3002808486-2024-00066
• Device Sequence Number: 1
• Product Code: MIH
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-28-155-W1
• Device Lot Number: E4491030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• 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 Sex: Female