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-28-201-W1

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).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

Description of event according to initial reporter: on (b)(6) 2024 at 4:00 am, patient was underwent emergency tevar for thoracic descending aortic rupture (maximum diameter approximately 70 mm) approached from the right fa.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-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.During procedure it was difficult for the device to pass over the bend in the artificial blood vessel at the distal arch.On (b)(6) 2024 the patient developed bradycardia while eating 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.Physician commented, "the exact cause of aneurysm re-rupture is unknown." therefore, it is unclear whether zenith products are the cause.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.

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 arteria.The rupture was likely around the thoracic vertebrae 9-10 and the descending aorta was aneurysmal along its entire length.There was a history of total arch replacement (tar) surgery on the proximal side, and there was an artificial blood vessel up to the distal arch.It is described that it was difficult for the device to pass over the bend in the artificial blood vessel at the distal arch.It is described that the procedure was within the applicable range and 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 from previous repair (2 stents are placed over the elephant trunk to the position where 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 (related complaint, pr426990) an esbe was implanted distally, just above the celiac.The final contrast showed no endoleak within the aneurysm, and the procedure was completed.On april 2nd, 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¿.It is therefore assumed that the re-rupture is around the zta-p-28-201-w1.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 elephant trunk.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, aneurysm rupture and death 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.A clinical assessment was made by a medical advisor based on the available information on 11apr2024.Per clinical assessment, "based on the limited information it is not possible to establish an exact cause to the re-rupture." however, it is unknown if the zta used in combination with the elephant trunk and/or the zta used for a ruptured aneurysm could have contributed to the event.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): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 19103566
• MDR Text Key: 340100403
• Report Number: 3002808486-2024-00063
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-28-201-W1
• Device Lot Number: E4496599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/15/2024
• 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: 01/16/2024
• 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 Outcome(s): Death
• Patient Sex: Female