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 Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site:(b)(4).Similar to devices under pma/510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the physician placed zta-pt-38-34-217-w1 in zone4 by advancing it from the left femoral artery with the cutdown approach.Then, he attempted to insert the complaint zta-p-40-167-w1 into the left fa as usual, but he felt resistance like the sheath tip got stuck at blood vessel access.He removed the complaint device once.He visually viewed a slight gap between the sheath and the dilator, so he tried to eliminate the gap and retried to insert the complaint device.However, he felt resistance again and removed the device.He visually checked the part between the sheath and dilator.Also, he palpated it and felt there was splinters.He thought it could lead to vascular injury if he inserted the device into the vessel forcibly.As a result, he replaced it with zta-p-40-217-w1 (longer than the complaint device) by push technique to complete the procedure.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: no product was returned and no information about patient anatomy was given.A photo of the damaged sheath tip was provided.The photo shows a small flap protruding from the sheath tip.According to the description of event it is likely that the gap between the sheath and the dilator that occured when removing the stylet from the dilator and the effort to eliminate the gap contributed to the advancement difficulty, however an exact cause of the event cannot be determined based on the provided information.According to the ifu: take care not to advance the sheath while the stent graft is still within it.Advancing the sheath at this stage may cause the barbs to perforate the introducer sheath.No evidence to suggest that the product was not manufactured according to specifications.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.

• 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
• MDR Report Key: 8136666
• MDR Text Key: 130045418
• Report Number: 3002808486-2018-01411
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449661
• UDI-Public: (01)10827002449661(17)210102(10)E3670097
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: ZTA-P-40-167-W1
• Device Lot Number: E3670097
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2018
• Device Age: 10 MO
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 73