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

Catalog Number TGU373720J

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2016, the patient underwent endovascular repair of a dissecting thoracic aortic aneurysm using conformable gore® tag® thoracic endoprosthesis.It was reported prior to the ctag being implanted an elephant-trunk procedure was performed.Imaging reportedly did not identify an endoleak.The physician closed the chest and concluded the procedure.The patient tolerated the procedure and was transferred to the icu.The same day, the imaging identified a rupture of the descending aorta located in the distal edge of partial uncovered stent of tgu373720j.An additional conformable gore® tag® thoracic endoprosthesis was implanted for distal extension to treat the rupture.The patient tolerated the procedure.It was reported additional information is not available.

• 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: marcos ayala ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5455866
• MDR Text Key: 38861545
• Report Number: 2017233-2016-00157
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2018
• Device Catalogue Number: TGU373720J
• Device Lot Number: 13857954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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: 85 YR