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-36-161-W1

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) pma/510(k): p140016.H6) a-code: a050408 - endoleaks.Investigation is still in progress.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.

Event Description

Description of event according to initial reporter: primary disease: arch aortic aneurysm.Patient anatomy before surgery and at the time of failure: the proximal neck length is about 15 mm on the lesser curvature side.Range of anatomical indications: although the proximal neck length was short and its use was off-label, tevar (thoracic endo vascular aortic repair) was selected as a means of potentially avoiding open chest surgery.Devices used: zta-p-36-161-w1 (lot# e4298471) approached from the left femoral artery to the aortic arch.Zta-p-36-113-w1 (lot# e4262998) approached from the left femoral artery to the aortic arch.Zta-p-36-161-w1 (lot# e4298472) approached from the left femoral artery to the aortic arch.Lunderquist / extended double curved.On (b)(6) 2022: as in the usual procedure, zta-p-36-161-w1 (lot# e4298471) was inserted along the lunderquist/extensded double curved, and aligned and deployed just below the left common carotid artery.Since type 1a endoleak was observed, zta-p-36-113-w1 (lot# e4262998) was deployed in the same position ((b)(4)).When touch-up was performed using a balloon catheter from another manufacturer, the stent graft fell into the aneurysm due to blood flow (migration), so zta-p-36-161-w1 (lot# e4298472) was deployed directly under the left common carotid artery.The procedure was completed after confirming the disappearance of the endoleak ((b)(4)).On (b)(6) 2023: the diameter of the aneurysm had been steadily decreasing, but at the follow-up ct on (b)(6) 2023, migration of the stent graft was observed, type 1a endoleak appeared, and the aneurysm diameter has been enlarged ((b)(4)).An open thoracotomy (total arch replacement) was considered, but it has been planning to perform tevar again, considering that the endoleak had been stopped at one time.

Manufacturer Narrative

Manufacturer ref#(b)(4) summary of investigational findings: on (b)(6) 2022 a 76 year old female patient underwent tevar (thoracic endovascular aortic repair) to treat an arch aortic aneurysm using a zta-p-36-161-w1 (complaint device).The patient anatomy and location of the aneurysm meant that the proximal landing zone was short, about 15mm, but despite the off-label use of zta-p-36-161-w1 tevar was selected as a means of potentially avoiding open chest surgery.The zta-p-36-161-w1 was inserted along a lunderquist / extended double curved guidewire and deployed just below the left common carotid artery.A type 1a endoleak was observed and it was decided to insert a zta-p-36-113-w1 in the same position to create a seal and resolve the endoleak.When touch-up was performed using a gore/tri-lobe balloon catheter, the stent graft fell into the aneurysm due to blood flow ((b)(4) mfg refr#3002808486-2023-00269), so another zta-p-36-161-w1 was deployed directly under the left common carotid artery.The procedure was completed after confirming the disappearance of the endoleak.At a follow-up ct on (b)(6) 2023, migration of the stent graft was observed, type 1a endoleak appeared, and the aneurysm diameter has been enlarged.((b)(4) mfg ref#3002808486-2023-00270) as the ifu states ¿proximal and distal aortic neck lengths should be a minimum of 20 mm.¿ and the use in this case is therefore considered outside the instructions for use (ifu).Although the physician knew that the landing zone was shorter than indicated by the ifu he decided on tevar to avoid open surgery.Review of the device history record gave no indication of the device being produced out of specification.Based on review of currently available information it has not been possible to determine an exact cause for the type 1a endoleak.No planning/sizing information is provided and therefore it is not possible to determine whether the choice of diameter in relation to the patient anatomy could have contributed to the type 1a endoleak.Without imaging from the procedure it is not possible to assess in detail the nature of the endoleak which could have helped deduce a cause.The most likely cause for the type 1a endoleak based on available information is that the short proximal landing zone contributed to a poor seal.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 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: 18017938
• MDR Text Key: 326678482
• Report Number: 3002808486-2023-00256
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449586
• UDI-Public: (01)10827002449586(17)250830(10)E4298471
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-36-161-W1
• Device Lot Number: E4298471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female