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

Catalog Number	TGT3420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/24/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: tgt4020/7495482 - udi: (b)(4), tgt4020/7495484 - udi: (b)(4).The gore® tag® endoprothesis instructions for use (ifu) states: complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: neurologic damage, local or systemic (e.G., stroke, paraplegia, death, infection (e.G., aneurysm, device or access sites).
Event or Problem Description
On (b)(6) 2010, this patient underwent a staged procedure for treatment of a descending thoracic aortic aneurysm.Vascular grafts were used to bypass to the celiac artery, the superior mesenteric artery and the bilateral renal arteries and maintain blood flow.A gore® tag® thoracic endoprosthesis was implanted distal to the left subclavian artery.The patient tolerated the procedure.On (b)(6) 2010, a second staged procedure was performed and three additional gore® tag® thoracic endoprostheses were implanted.The patient tolerated the procedure.On (b)(6) 2010, it was reported that the patient experienced paraparesis.Further intervention was not performed.On (b)(6) 2010, at the six month follow up for the study, the patient's paraparesis persisted.On (b)(6) 2011, at the one year follow up for the study, the patient's paraparesis persisted.On (b)(6) 2012, the patient went into cardiopulmonary arrest in his home.The patient was emergently admitted to the hospital wherein he expired later this same day.

• 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: 8348780
• Report Number: 2017233-2019-00087
• Device Sequence Number: 2035498
• Product Code: MIH
• UDI-Device Identifier: 00733132613656
• UDI-Public: 00733132613656
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2014

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: 01/31/2013
• Device Catalogue Number: TGT3420
• Device Lot Number: 7573667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2019
• 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: Hospitalization
• Patient Age: 76 YR