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-40-167-W1

Device Problem Mechanical Jam (2983)

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

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Device marketed under pma/510(k): p140016.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: when the introduction system of zta-p-40-167-w1 (lot#: e4009372) was inserted into the right femoral artery, resistance was felt.When it was taken out, the tip of the sheath appeared to have been swollen and crushed.It was confirmed that the sheath could be withdrawn on the operating table, however it was unable to restore it to the original state.The procedure was continued by changing the device with another zta-p-40-167-w1 (lot#: e4151598) ((b)(4)).As for the replacement device zta-p-40-167-w1 (lot#: e4151598) the blue rotation handle was turned in the direction of the arrow until a stop was felt as the instructions for use says, however the bare alignment stent was not expanded.In the end, the bare alignment stent was expanded by pulling the release wires themselves after disassembling the blue rotation handle.At this point, the proximal part of the stent graft migrated to the distal position, so zta-de-42-94-w1 (lot#: e4002762) was added to the proximal position.No endoleak was observed ((b)(4)).Patient outcome: no adverse effect on the patient has been reported.

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: when operating the replacement zta-p-40-167-w1 (complaint complaint), the blue rotation handle was turned in the direction of the arrow until a stop was felt as per instructions for use (ifu), however the bare alignment stent was not expanded.In the end, the bare alignment stent was expanded by pulling the release wires after disassembling the blue rotation handle.At this point, the proximal part of the stent graft migrated to the distal position, so zta-de-42-94-w1 was added in proximal position.No endoleak was observed.Patient´s anatomy in the area of the difficulty was reported with no vessel calcification and no tortuosity.No adverse effects on patient have been reported.This complaint is related to (b)(4).(fda ref# 3002808486-2023-00174).No imaging was provided.Zta-p-40-167-w1 was returned without shipping stylet, stent graft, backend cap and back-end cap retaining clips and a device evaluation was performed.During the device evaluation, a nonconformance on the nitinol release wires was observed.As troubleshooting was performed and the stent graft was deployed by customer, the device evaluation could not confirm or unconfirm whether the rotation handle was rotated to stop.It may be speculated whether the nonconformance on the nitinol release wires could contribute to customer experiencing a false stop (partly retraction of wires) during rotation of the blue rotation handle.However, since the rotation handle on the device was dismounted during troubleshooting, it was not possible to determine whether the wires were partly retracted or not.A request for an internal action was initiated to address the nonconformance on the nitinol release wires and if the nonconformance could influence release of stent graft.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, dk-4632; bjaeverskov
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16563637
• MDR Text Key: 311479560
• Report Number: 3002808486-2023-00062
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449661
• UDI-Public: (01)10827002449661(17)240901(10)E4151598
• 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: 09/06/2023

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-40-167-W1
• Device Lot Number: E4151598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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