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
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Occupation: non-healthcare professional.Pma/510k: p140016.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: deployed graft on back table and noticed bare metal stent was not attached to graft.Physician modified graft for repair of dissection of aorta around visceral vessels.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a 70 years old male patient with dissection in visceral arteries should undergo tevar with zta-pt-32-28-178-w.It was reported that the physician unsheathed the device in an operation table and were in the process of removing the barbs at the proximal end of the graft.This was done by using a heavy duty needle driver and twisting off the barbs.It was noticed that an apex of bare alignment stent was not fixed to the graft material.The physician sutured apex to the graft, reloaded the stent graft and deployed it into the patient.No adverse events were reported.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.Moreover, it states that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the patients with dissections.The instructions for use also states, that the extreme caution should be exercised, when manipulating interventional and angiographic devices in the region of the uncovered proximal stent and uncovered distal stent.Per the instructions for use, it must not be attempted to resheath the graft after partial or complete deployment.Furthermore, the device must not be used if damage has occurred.Instead, it should be return to cook.Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient.Based on the provided information, imaging and cook´s documentation, an exact cause of the reported event cannot be established.However review of the device history record gave no indication of the device being produced out of specification.It is possible that the damage occurred during design modification.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 TAPERED COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11341583
• Report Number: 3002808486-2021-00124
• Device Sequence Number: 17392663
• Product Code: MIH
• UDI-Device Identifier: 10827002380759
• UDI-Public: (01)10827002380759(17)230701(10)E3993725
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: G38075
• Device Catalogue Number: ZTA-PT-32-28-178-W
• Device Lot Number: E3993725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR