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

Catalog Number	TGT3115
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On unknown date, total arch replacement was performed using a surgical graft.On (b)(6) 2011, the patient underwent treatment of a thoracic aortic aneurysm with two gore® tag® thoracic endoprostheses (proximal-tgt3115, distal-tgt3420).The proximal end of the tgt3115 was placed in the distal anastomosis of the surgical graft.The procedure was finished with no evidence of endoleak.The patient tolerated the procedure.On unknown date, it was identified that the tgt3115 was migrated distally.There was an unknown leak between the distal anastomosis and the tgt3115.An intravascular ultrasound (ivus) was performed in order to determine the origin of the leak, but it was not able to determine the exact origin of the leak.The physician reportedly stated that the exact cause of the leak was unknown.The flare (the proximal end) of the tgt3115 might have caused a damage to the surgical graft and it resulted in a leak from the surgical graft.On (b)(6) 2018, the patient underwent secondary intervention to treat the unknown leak.A conformable gore tag® thoracic endoprosthesis (b)(4) was implanted covering the distal anastomosis of the surgical graft and the proximal end of the tgt3115.A post-ballooning was performed.The unknown leak was resolved.The patient tolerated the procedure.

• 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: 8053259
• Report Number: 2017233-2018-00668
• Device Sequence Number: 1586224
• Product Code: MIH
• UDI-Device Identifier: 00733132613625
• UDI-Public: 00733132613625
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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: 03/31/2014
• Device Catalogue Number: TGT3115
• Device Lot Number: 9042283
• 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: 11/08/2018
• 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; Required Intervention
• Patient Age: 76 YR