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

Model Number	G53431
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported by the manufacturer under mdr#3002808486-2019-01674.
Event or Problem Description
Protocol 08-005: patient (b)(6) ¿ endoleak (type unknown) on (b)(6) 2015, the patient received a zteg-2p-36-152-pf-us (lot # e2977967).There were no difficulties deploying the device.No patient-related adverse events were observed during the procedure.Per site and core lab, the device was patent with no kink or endoleak on the completion angiogram.The patient was discharged from the hospital on (b)(6) 2015 (one day post-procedure).(b)(6) 2015 (81 days post-procedure) follow-up ct scan: site review: patent, intact graft with no endoleak.The maximum aneurysm diameter measured 61 mm.Core lab review: patent, intact graft with no evidence of kink or endoleak.The maximum aneurysm diameter measured 62.8 mm and the aneurysm length measured 75.2 mm.(b)(6) 2015 (289 days post-procedure) six-month follow-up ct scan: site review: patent, intact graft with no evidence of migration or endoleak.The maximum aneurysm diameter measured 45 mm.Core lab review: patent, intact graft with no evidence of kink, endoleak, or migration.The maximum aneurysm diameter measured 51.6 mm and the aneurysm length measured 69.6 mm.(b)(6) 2016 (548 days post-procedure) 12-month follow-up ct scan: site review: patent, intact graft with no migration or endoleak.The maximum aneurysm diameter was 45 mm.Core lab review: patent, intact graft with no evidence of kink, migration, or endoleak.The maximum aneurysm diameter measured 52.7 mm.(b)(6) 2017 (917 days post-procedure) 2-year follow-up ct scan: site review: patent, intact graft with no evidence of migration or endoleak.The maximum aneurysm diameter was 40 mm.Core lab review: patent, intact graft with no evidence of kink, migration, or endoleak.The maximum aneurysm diameter measured 49.0 mm.The three year clinical assessment and imaging were not completed.On (b)(6) 2018 (1393 days post-procedure), the patient underwent endovascular intervention for a pre-existing distal thoracic aortic aneurysm and was discharged on (b)(6) 2018.On (b)(6) 2019 (1428 days post-procedure) 4-year follow-up ct scan: site review: patent, intact graft with no evidence of migration or endoleak.The maximum aneurysm diameter was 48 mm.Core lab review: patent, intact graft with no evidence of kink or migration.An endoleak (type unknown) was identified.The maximum aneurysm diameter measured 63.9 mm.The core lab noted, ¿since the 24mo study, new devices have been placed extending the device at both the proximal and distal ends.The new devices were placed to treat an enlarging taa distal to the initial devices.The study taa is enlarging with a new endoleak present.The source of the leak is not clearly demonstrated, but may be a type iv.¿ additional information received 01oct2019 from cri: shape of neck anatomy: "site reports parallel, core lab reports irregular".

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL 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: 9209080
• Report Number: 3005580113-2019-00590
• Device Sequence Number: 447281
• Product Code: MIH
• UDI-Device Identifier: 10827002534312
• UDI-Public: (01)10827002534312(17)150912(10)E2977967
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section F): 10/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2015
• Device Model Number: G53431
• Device Catalogue Number: ZTEG-2P-36-152-PF-US
• Device Lot Number: E2977967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2019
• Date Report to Manufacturer: 10/01/2019
• 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: 80 YR
• Patient Weight: 61