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

Catalog Number TG4010

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/14/2010

Event Type  Injury  

Manufacturer Narrative

Additional device implanted and involved in the event: tg4015/06423615.Udis for the lots are as follows: (b)(4).(b)(6).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The cause of the aneurysm growth is unknown.

Event Description

(b)(6) 2009, the patient underwent a procedure using two goretagthoracic endoprostheses to treat a thoracic aneurysm.It was reported that on discharge date of (b)(6) 2009, the aneurysm measured 62.2mm.Follow up dates and aneurysm measurements are as follows: (b)(6) 2010 - 65.2mm; and (b)(6) 2010 - 68.5mm.It is unknown why the aneurysm sac has enlarged and there has been no reported or planned reintervention.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 86001
• Manufacturer Contact: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5338827
• MDR Text Key: 34808034
• Report Number: 2017233-2015-00929
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2015

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: 04/30/2010
• Device Catalogue Number: TG4010
• Device Lot Number: 05095158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• 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: 75 YR
• Patient Weight: 79