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

Catalog Number TGU282815J

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to: reoperation.

Event Description

On (b)(6) 2018, the patient was implanted with a conformable gore® tag® thoracic endoprosthesis to treat a thoracic aortic aneurysm.On (b)(6) 2018, a follow-up computed tomography scan reportedly identified a suspected type iii endoleak (tear/disruption in graft material).No aneurysm enlargement was observed.On (b)(6) 2018, the patient underwent a secondary re-intervention procedure to treat the suspected endoleak at the patient's request.According to the report, an intra-operative angiograph showed no obvious evidence of a proximal type i or type iii endoleak.An additional conformable gore® tag® device was implanted proximal to the previously implanted endoprosthesis.The procedure was completed with no reported evidence of endoleak, 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: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 7873291
• MDR Text Key: 120154520
• Report Number: 2017233-2018-00554
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: TGU282815J
• Device Lot Number: 17617304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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): Other
• Patient Age: 91 YR