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

Model Number	G35351
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "the zta-p-34-161-w was deployed in the descending thoracic aorta.There was evidence of a type 1b endoleak on the angiogram.The zta-p-34-113-w was then deployed distal to 1st device.The zta-p-38-117 was deployed proximal to the 1st device.Patient presented to the er at a neighboring hospital and was transferred for an emergent branch repair." additional information received 07jan2020: at the final angiogram, a type ib endoleak was noted and a second stent graft was placed distal to the graft.A third stent was placed to get a better seal zone.Tbranch was noted for future treatment if necessary.The endoleak was discovered post angiogram on the initial implant on (b)(6) 2016.Additional stent was placed to resolve endoleak." patient outcome: unknown.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) summary of investigational findings: a patient had a zta-p-34-161-w implanted on (b)(6) 2016 in the descending thoracic aorta.A type 1b endoleak was seen on the final angiogram why a zta-p-34-113-w was deployed distal to the complaint device.This resolved the endoleak.Furthermore, a zta-p-38-117 was deployed proximal to the complaint device to improve the seal zone.This complaint is related to (b)(4) (manufacturer report# 3002808486-2020-00027) which deal with a fracture on the zta-p-34-161-w discovered on (b)(6) 2019.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use sent with this device, endoleak is a known potential adverse event.Based on the very limited information provided for this complaint it has not been possible to establish an exact cause for this event.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.
Event or Problem 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 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: 9584743
• Report Number: 3002808486-2020-00026
• Device Sequence Number: 3389810
• Product Code: MIH
• UDI-Device Identifier: 10827002353517
• UDI-Public: (01)10827002353517(17)190524(10)E3452145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: G35351
• Device Catalogue Number: ZTA-P-34-161-W
• Device Lot Number: E3452145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention