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

Model Number G38075

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Device Damaged Prior to Use (2284); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: prosthetics and supply coordinator.Investigation is still in progress.

Event Description

Description of event according to initial reporter: upon deployment of the modified graft, the delivery system was in the process of being removed when it seemed to get caught up on the graft as it was being removed.It was then noticed that the graft seemed to have moved distal to where it was released causing a shift from where it was originally at.The celiac artery was then unable to be cannulated.It was noted after finally removing the delivery system that one of the trigger wires was still able to be seen on the system where it should have been rotated into the handle.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: upon deployment of the zta-pt-32-28-178-w (complaint device) the delivery system seemed to get caught up on the graft.It was then noticed that the stent graft seemed to have moved distally.The celiac artery was then unable to be cannulated.Per the reported information, the rotational handle was rotated to stop.The delivery system was removed to be replaced with a gore dry-seal sheath when there was some resistance noted at the distal end of the graft.One trigger wire was noted to be still visible at the end of the dilator.Per the reported information, the complaint device has been modified to a pmeg (physician-modified endograft) fenestrated graft for a thoracoabdominal aneurysm.4 fenestrations have been made with diameter reducing ties on the posterior side of the graft.An additional alpha stent graft has been used as an extension to achieve seal proximally and the celiac artery was observed to be patent.The complaint device was returned and evaluated.Per device evaluation, the rotation handle was rotated to stop.It was visually confirmed as the threaded wire knob with trigger wires and steel wire was rotated to the stop tube.The inside of the rotation handle did not show signs of manipulation or damages.The evaluation of the introduction system showed a hole in the uat near the gray positioner.The shape of the hole could indicate that it was cut open and a part of the uat material was removed.One of the trigger wires were going out of a hole, where as the other two were still inside the uat.The event description reports that ¿it was noted after finally removing the delivery system that one of the trigger wires was still able to be seen on the system where it should have been rotated into the handle¿.On the returned device, all three trigger wires and the steel wire were retracted as expected on an unmodified device.The steel wire attaches the distal end of the stent graft to the gray positioner and was retracted into the gray positioner on the returned device.The trigger wires (including the one wire pointing out of the observed uat hole) were retracted past the proximal attachment in the uat, that keeps the proximal end of the stent graft to the introduction system.From the event information, it is not clear whether the stent graft modification was performed while the stent graft was attached to the introduction system or if the wires were fully detached from the stent graft during the modification and then attached to the stent graft again after the modification.However, as the stent graft is a zta-pt with proximal barbs, the barbs will perforate the sheath, if the sheath was retracted and resheathed while the stent graft was attached to the introduction system.Review of the device history record gave no indication of the device being produced out of specification.Device modification is not supported by the instructions for use or clinical testing of the device.Based on the provided information and device evaluation it has not been possible to establish a conclusive cause of the reported event as the stent graft and possibly the attachment of the stent graft to the introduction system was modified before use.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.

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 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12735553
• MDR Text Key: 279547795
• Report Number: 3002808486-2021-01939
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002380759
• UDI-Public: (01)10827002380759(17)240413(10)E4096081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38075
• Device Catalogue Number: ZTA-PT-32-28-178-W
• Device Lot Number: E4096081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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: 73 YR
• Patient Sex: Male