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

Catalog Number TGU373710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 07/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: gore® tag® thoracic endoprosthesis tgu454520, (b)(4).Results: (b)(4): a review of the manufacturing records for the devices verified the lots met all pre-release specifications.A review of the sterilization records for the devices verified the lots met all pre-release sterilization specifications.Conclusion: (b)(4): according to the conformable gore tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: infections.

Event Description

The following information was reported to gore: on (b)(6) 2016 a patient underwent thoracic endovascular repair of a descending thoracic aortic aneurysm with two conformable gore® tag® thoracic endoprostheses.The left femoral artery was used for access.On (b)(6) 2016 the patient presented with (b)(6) left femoral surgical incision infection.This was treated by means of irrigation and debridement in a surgical setting.

Event Description

The following information was reported to gore: on (b)(6) 2016 a patient underwent thoracic endovascular repair of a descending thoracic aortic aneurysm with two conformable gore® tag® thoracic endoprostheses.The left femoral artery was used for access.A cordis bright tip sheath was utilized.On (b)(6) 2016 the patient presented with (b)(6) left femoral surgical incision infection.This was not a pre-existing infection.The infection was treated by means of irrigation and debridement in a surgical setting.Antibiotics were administered, both iv and oral.On (b)(6) 2016 the wound care rn reported the femoral artery site infection had resolved.As of (b)(6) 2017 the patient was doing well.

• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6216546
• MDR Text Key: 63687156
• Report Number: 2017233-2016-00965
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

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: 06/30/2018
• Device Catalogue Number: TGU373710
• Device Lot Number: 14209627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 140