MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGT4020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
On unknown date in (b)(6) 2013, this patient underwent an endovascular treatment for an aortic dissection using a gore® tag® thoracic endoprosthesis.At the follow up on unknown date, aortic enlargement of the distal landing zone was confirmed.Since there was no endoleak detected, the patient was monitored.Thereafter, the diameter of the descending aorta enlarged to 60 mm or greater.On (b)(6) 2020, the patient underwent an additional procedure whereby a conformable gore® tag® thoracic endoprosthesis was implanted distally of previously implanted gore® tag® thoracic endoprosthesis.The cause of aortic enlargement was unknown.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data - event: added date of procedure.
Event or Problem Description
On (b)(6) 2013 this patient underwent an endovascular repair for an aortic dissection using tgt4020, gore tag stent graft.At the follow up on unknown date, aortic enlargement of distal landing zone was confirmed.Since there was no endoleak detected, the patient was monitored.Thereafter, the diameter of the descending aorta enlarged to 60 mm or greater.On (b)(6) 2020, the patient underwent an additional procedure whereby a tgmr404020j was implanted distally of tgt4020.The cause of aortic enlargement was unknown.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9744869
• Report Number: 2017233-2020-00124
• Device Sequence Number: 1814929
• Product Code: MIH
• UDI-Device Identifier: 00733132613717
• UDI-Public: 00733132613717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: TGT4020
• Device Catalogue Number: TGT4020
• Device Lot Number: 10314039
• 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: 02/24/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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: Required Intervention
• Patient Age: 76 YR