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

Catalog Number TGT4015

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Therapeutic Response, Decreased (2271)

Event Date 05/24/2011

Event Type  Injury  

Manufacturer Narrative

Additional tag® device included in this report: tgt4020/8394167.Device udi¿s: lot #8257352: (b)(4).Lot #8394167: (b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The gore® tag® thoracic endoprosthesis instructions for use state that potential device or procedure related adverse events include aneurysm enlargement.

Event Description

On (b)(6) 2010, the patient underwent a procedure using two gore tag thoracic endoprostheses (tgt4015/8257352 and tgt4020/8394167) to treat a thoracic aneurysm.It was reported that on discharge date of (b)(6) 2010, the aneurysm measured 24.0 mm in diameter.Follow up dates and aneurysm measurement: (b)(6) 2011: 30.0 mm, (b)(6) 2011: 30.0 mm, (b)(6) 2012: 30.0 mm, (b)(6) 2014: 30.0 mm.The cause of the aneurysm enlargement is not known.There has been no reported re-intervention procedure to date.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: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5338663
• MDR Text Key: 34806358
• Report Number: 2017233-2015-00935
• 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: 07/31/2013
• Device Catalogue Number: TGT4015
• Device Lot Number: 8257352
• 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: 09/08/2010
• 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: 83 YR
• Patient Weight: 62