MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU212110
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® tag® thoracic endoprosthesis provides endovascular repair of the descending thoracic aorta (dta).A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for infrarenal aortic dissection and was implanted with a conformable gore tag® thoracic endoprostheses (ctag).It was reported that there was partial unintentional coverage of the left renal artery.There was no deficiency of the device reported.The patient tolerated the procedure.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment for infrarenal aortic dissection and was implanted with a conformable gore tag® thoracic endoprostheses (ctag).It was reported that there was partial unintentional coverage of the right renal artery.There was no deficiency of the device reported.The patient tolerated the procedure.On (b)(6) 2019, the patient was reported to be experiencing renal function.Computed tomography was performed this date and showed complete coverage of the right renal artery.The patient underwent reintervention and the was converted to open repair and the conformable gore tag® thoracic endoprostheses was explanted.The patient tolerated the reintervention.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8376343
• Report Number: 2017233-2019-00086
• Device Sequence Number: 1332345
• Product Code: MIH
• UDI-Device Identifier: 00733132617777
• UDI-Public: 00733132617777
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2019
• Device Catalogue Number: TGU212110
• Device Lot Number: 15952249
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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: Hospitalization; Other
• Patient Age: 49 YR
• Patient Weight: 136