MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU343410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2015, this patient underwent endovascular treatment of an thoracic aortic aneurysm using a conformable gore tag thoracic endoprosthesis.Follow up showed what appeared to be a "fractured or disconnected" gore tag device.On (b)(6) 2020, a reintervention occurred whereby the device was relined.Additional information has been requested.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative images were evaluated by gore imaging sciences: ¿ eight time-points were submitted for evaluation.¿ 2015, 2016, 2017, 2018 and 2019 ¿ there appears to be a single device implanted that measures ~ 10 cm in length along the outer curve.¿ diameter within the proximal end of the graft measures ~ 24 mm in 2015 and ~ 33 mm in 2016, 6/2017, 12/2017, 2018 and 2019.¿ there appears to be lack of wall apposition at the proximal end of the implanted device in 2016, 6/2017, 12/2017, 2018 and 2019.¿ (b)(6) 2020 ¿ there appears to be a disruption in wire pattern near the proximal end of the implanted device.¿ diameter within the proximal end of the graft measures ~ 24 mm in 2015 and ¿ ~ 33 mm in 2020 ¿ there appears to be lack of wall apposition at the proximal end of the implanted device.¿ there appears to be a contrast-like density present outside of the implanted device.¿ contrast cannot be confirmed with available image set, arterial phase only.¿ (b)(6) 2020 ¿ there appears to be two devices implanted, the proximal device appears to measure ~ 15 cm in length along the outer curve, the distal device appears to measure ~ 10 cm in length along the outer curve.¿ the contrast-like density visualized on cta dated (b)(6) 2020 is not visualized on the arterial phase images.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10359293
• Report Number: 2017233-2020-01074
• Device Sequence Number: 2432437
• Product Code: MIH
• UDI-Device Identifier: 00733132617807
• UDI-Public: 00733132617807
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: TGU343410
• Device Catalogue Number: TGU343410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 07/06/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 11/26/2020; 01/25/2021
• 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: 80 YR