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

Catalog Number TGU262615J

Device Problem Torn Material (3024)

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

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to dissection.

Event Description

On (b)(6) 2017, the patient was implanted with gore® tag® thoracic endoprostheses (proximal: tgu313120j/13185391, distal: tgu262615j/12629149) to treat a thoracic aortic dissection.The stentgrafts were implanted without issue.The patient tolerated the procedure.On date unknown, a follow up computed tomography (ct) revealed a new tear at distal edge of tgu262615j and a new re-entry at left common iliac artery.On (b)(6) 2017, the patient was implanted with two aortic extender component to cover the tear and was implanted with contralateral leg component to cover the re-entry.The re-intervention was concluded without issue.No further information is 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: akira sori ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6496720
• MDR Text Key: 72918448
• Report Number: 2017233-2017-00203
• 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: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: TGU262615J
• Device Lot Number: 12629149
• 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: 05/12/2014
• 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): Required Intervention
• Patient Age: 58 YR