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

Model Number	TGU404010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the conformable gore tag thoracic endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that adverse events that may occur and / or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular treatment of a thoracic aortic aneurysm using conformable gore tag thoracic endoprostheses.A tgu343410 was deployed proximal, and a tgu404010 was then placed distally.The overlap of the devices was greater than 3 cm.On (b)(6) 2019, 5-month follow-up cta scan showed a type ii endoleak with filling of the intercostals arteries.The aneurysm increased in size from 66 mm at baseline to 68 mm.The physician opted to repeat a cta in a year.On (b)(6) 2020, the more recent cta showed continued growth to 76 mm.There also appeared to be a type iii endoleak on the inner curve of the two devices.There appeared to be some ¿bird beaking¿ of the tgu404010 device.This was confirmed with an angiogram on (b)(6) 2020, and the entire stented segment was relined using a single tgmr404015 device.Final angiograms showed complete resolution of the endoleak.

• 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: 10369156
• Report Number: 2017233-2020-01083
• Device Sequence Number: 19047404
• Product Code: MIH
• UDI-Device Identifier: 00733132617739
• UDI-Public: 00733132617739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 08/05/2020

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: 01/10/2020
• Device Model Number: TGU404010
• Device Catalogue Number: TGU404010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/05/2020
• 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: 82 YR