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

Catalog Number	TGU343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular repair of a type b complicated aortic dissection using a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2019, the patient presented with worsening baseline hypertension, leading to concern for development of malperfusion of the visceral segment (including renals).The patient also had issues with lumbar drain placement, so a diagnostic angiogram was completed (b)(6) 2019.On (b)(6) 2019, the patient underwent a tevar graft extension to improve hemodynamics in perivisceral aorta.The patient was discharged on (b)(6) 2019.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8745201
• Report Number: 2017233-2019-00480
• Device Sequence Number: 11393781
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: 04/30/2016
• Device Catalogue Number: TGU343420
• Device Lot Number: 11453031
• 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: 06/28/2019
• 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: Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 117