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

Catalog Number TGU373720J

Device Problems Patient-Device Incompatibility (2682); Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

It is unknown which device caused this adverse event so all devices are being included on this report.Additional devices include: item #tgu373720j/lot #16453966/ udi # (b)(4).The review of the manufacturing paperwork verified that the lots met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak and reoperation.

Event Description

On (b)(6) 2012 the patient underwent endovascular repair of a thoracic aortic aneurysm using a non-gore device (cook zenith tx2).A bypass procedure was performed, and the patient's left subclavian artery was embolized using a plug.On (b)(6) 2018 conformable gore® tag® thoracic endoprostheses (ctag devices) were implanted proximal to the non-gore device to repair a proximal type i endoleak.The physician performed an aortic banding procedure, and the ctag devices were placed in a parallel course adjacent to the previously implanted device (chimney technique).The physician noted that, after completion of the banding procedure, the diameter of the patient's thoracic aorta was shrunk to approximately 31 mm.Reportedly the area where the banding was performed was not elastic.Post deployment imaging was completed and an endoleak was identified.Reportedly the physician suspected that the endoleak was either a proximal type i or a type ii endoleak.It was suspected that the banding procedure may have led to invagination of the ctag device, and subsequent endoleak.The physician opted to monitor the patient.No treatment was performed to treat the endoleak.On an unknown date in 2019 (reported as about one year after the ctag devices were implanted), follow-up imaging revealed a type ii endoleak originating from the patient's left subclavian artery.No aneurysm enlargement was noted.On (b)(6) 2019 the left subclavian artery was coil embolized to repair the type ii endoleak.After the treatment of the type ii endoleak, imaging identified a proximal type i endoleak.On (b)(6) 2019 a conformable gore® tag® thoracic endoprosthesis with active control was used to reline the previously implanted ctag device to repair the proximal type i endoleak.There were no further reported issues.

Manufacturer Narrative

H.6.Patient code 1 updated.

• 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
• MDR Report Key: 8732976
• MDR Text Key: 149160388
• Report Number: 2017233-2019-00461
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: TGU373720J
• Device Lot Number: 16259091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR