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

Catalog Number TGU313115J

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

Additional gore® tag® thoracic endoprosthesis included in this report: tgu404015j/16359483 udi¿s: (b)(4).A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to endoleak and reoperation.

Event Description

On (b)(6) 2017, the patient was implanted with two conformable gore® tag® thoracic endoprostheses to treat an aortic arch aneurysm.Bypass to the left common carotid artery (lcca) and the left subclavian artery (lsa) was performed prior to the procedure.A 31mm x 15cm gore® tag® device (tgu313115j/ 16359468) was deployed distally in the descending aorta, and a 40mm x 15cm gore® tag® device (tgu404015j/ 16359483) was then deployed just distal to the brachiocephalic artery as planned.The lcca and the lsa were covered by tgu404015j.According to the report, touch-up ballooning was performed only to the junction of the two endoprostheses.Final-angiography reportedly showed no endoleak, and the procedure was concluded.The patient tolerated the procedure.On an unknown date in (b)(6) 2017, follow-up imaging reportedly confirmed an unknown type of endoleak.On (b)(6) 2017, the physician opted to perform a re-intervention procedure.Intra-procedural angiography reportedly could not confirm any endoleak at that time.Touch-up ballooning was performed to the proximal end, and at the junction of the endoprostheses.The origin of the lsa was also coil embolized as a precautionary measure.Final angiography showed no evidence of endoleak, and the procedure was concluded.The patient tolerated the procedure.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 6892216
• MDR Text Key: 87293192
• Report Number: 2017233-2017-00497
• 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: 09/12/2017

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: 05/01/2020
• Device Catalogue Number: TGU313115J
• Device Lot Number: 16359468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR