MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G53447
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the manufacturer under mdr#3002808486-2019-01675.
Event or Problem Description
Description of event according to study: on (b)(6) 2014, the patient received zteg-2pt-36-197-pf-us (lot # e3219029) under general anesthesia.A coda-2-10.0-35-120-40 (lot # 4931829) molding balloon was used without difficulty or complication.No adverse events were reported related to the implant procedure.The patient has been followed by a series of cts (dates: (b)(6) 2014, (b)(6) 2015, (b)(6) 2017, (b)(6) 2018) with no device related issues reported.A (b)(6) 2019 ct revealed caudad migration.Core lab noted, ¿caudad (at the proximal end).L2 has increased more than 10mm, and the 3d reconstructions show a change in the relationship of the device to calcification in the aortic wall.¿ core lab also noted, ¿l2 has increased more than 10mm, and the 3d reconstructions show a change in the relationship of the device to calcification in the aortic wall.The device has partially overlapped the 3rd and 4th stents over time as angulation developed, which appears to have pulled the proximal aspect of the device in a caudad direction.L6 is now also >10mm increased over the 1 month time point.It is not clear that this is due to migration, as no definite anatomic markers are identified for direct comparison, and the overall aortic length has also increased.¿ no adverse events or secondary interventions have been reported related to this event.The patient remains in the study.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• 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: 9209153
• Report Number: 3005580113-2019-00591
• Device Sequence Number: 2639540
• Product Code: MIH
• UDI-Device Identifier: 10827002534473
• UDI-Public: (01)10827002534473(17)170526(10)E3219029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2019
• Report Date (Section F): 10/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2017
• Device Model Number: G53447
• Device Catalogue Number: ZTEG-2PT-36-197-PF-US
• Device Lot Number: E3219029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 83
• Date Report Sent to FDA: 10/18/2019