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

Catalog Number ZTA-PT-38-34-167-W1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular Dissection (3160)

Event Date 03/05/2024

Event Type  Injury  

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

Description of event according to initial reporter: patient anatomy before surgery and at the time of failure (access route): the left eia (external iliac artery) has calcification, and the smallest blood vessel diameter is 6.1mm.The right eia (external iliac artery) bare stent placed, tortuosity, minimum vessel diameter is 5mm.In a meeting with the physician the day before the surgery, it was determined that although it was difficult to determine whether the left side was better or worse, the left side was more likely, so the plan was to try the left side, and if that didn't work, then the right side.Range of anatomical indications: outside of anatomical indications the patient was 82 years old and had a history of open chest and abdominal surgery.Because the lesion was in the descending aorta, we decided to attempt thoracic endovascular aortic repair (tevar), considering the invasiveness of the surgical procedure and the fact that access might be difficult, but with the intention of withdrawing if delivery was not possible.A dummy trial was performed using gore/dryseal 18fr from the left femoral artery.The inner cannula (6.1mm) alone passed through eia, but the one with the outer cannula (6.7mm) did not.We performed pta (percutaneous transluminal angioplasty) on eia using an 8mm balloon and tried again with an outer cannula and confirmed that it passed.Therefore, we delivered zta-pt-38-34-167-w1 (7.1mm/lot# e4400227), but it could not pass through eia.Pta was attempted again, but the difference between the inner and outer cannula got caught in the calcification and delivery was not possible, so the approach was changed to from the right femoral artery.After performing pta on the right femoral artery and confirming that gore/dryseal 18fr passed through eia, zta-pt-38-34-167-w1 (lot# e4400227) was delivered, but the fray at the difference between the inner and outer cannula got caught on the indwelling bare stent and did not advance.However, the gore/dryseal had seemed to pass more smoothly than the left side, and the physician's feeling in his hand also determined that it could be delivered from the right side with less resistance than the left side.The physician shaved off the frayed part of the sheath and tried again, but the coating had peeled off and the sheath was also kinked.There was also a difference in the sheath part, which prevented the insertion force from being transmitted properly, and it was determined that trying again with zta-pt-38-34-167-w1 (lot# e4400227) would increase the risk of blood vessel damage, making delivery difficult.We replaced the device with zta-pt-38-34-167-w1 (lot# e4473009), performed delivery, and confirmed that it passed through eia.Tevar was performed according to the original plan.No endoleak was identified on final angiography and tevar was completed.Access angiography revealed dissection in the left eia, which was occurred as a result of delivery of zta-pt-38-34-167-w1 (e4400227), and boston scientific/epic (self-expanding nitinol stent system, f8mm-8cm) was placed and the procedure was completed.Additional information received 08mar2024: dissection of the left eia was not confirmed when angiography was performed to confirm access after balloon dilation (pta), so it is thought that it occurred when zenith was delivered.The flow of the procedure was as follows: gore/dryseal 18fr with the outer cannula (6.7mm) did not pass through the left eia pta gore/dryseal 18fr could pass through zta-pt-38-34-167-w1 (e4400227) did not pass through pta & angiography (at this point, dissection was not confirmed) zta-pt-38-34-167-w1 (e4400227) did not pass through again the access site was changed to the right femoral artery.The device was changed to zta-pt-38-34-167-w1 (e4473009) halfway and tevar was performed.Angiography confirmed no endoleak access angiography revealed dissection in the left eia boston scientific/epic was deployed.Patient outcome: no adverse effect on the patient has been reported.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 18892752
• MDR Text Key: 337512591
• Report Number: 3002808486-2024-00045
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448664
• UDI-Public: (01)10827002448664(17)260428(10)E4400227
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

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-PT-38-34-167-W1
• Device Lot Number: E4400227
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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: 82 YR
• Patient Sex: Male