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

Catalog Number TGU404015

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

As it is unknown what device the endoleak was attributed to, additional devices implanted: tgu404010/(b)(4) and tgu404010/(b)(4) have been listed.According to the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to: endoleak.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.

Event Description

On (b)(6) 2014, the patient was treated for a thoracic aortic aneurysm using endologix stent graft and conformable gore® tag® thoracic endoprostheses.On an unknown date, imaging identified a type iii endoleak component disconnect between the endologix device and a ctag device (lot number unknown).It was reported the cause of type iii endoleak is unknown.No aneurysm enlargement was reported.On (b)(6) 2018, a reintervention was performed bridging the two devices.The endoleak was reportedly resolved and the patient tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8238055
• MDR Text Key: 132769382
• Report Number: 2017233-2019-00019
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618163
• UDI-Public: 00733132618163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: TGU404015
• Device Lot Number: 10513063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR