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

Catalog Number TGU343415

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aortic Dissection (2491)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: the patient¿s medications include; lasix, calcium, pradaxa, levothyroxine, protonix, valsartan and metoprolol.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis that may occur and/or require intervention include, but are not limited to persistent false lumen flow, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, and reoperation.

Event Description

On (b)(6) 2018, the patient underwent endovascular treatment of a thoracic aortic dissection with a conformable gore® tag® thoracic endoprosthesis.It was reported the left subclavian artery was intentionally covered during the initial implantation procedure.On (b)(6) 2018, follow-up imaging identified distal false lumen perfusion within the treated area with distal extension of the dissection.On (b)(6) 2018, an intervention was performed, whereby an additional tag device was implanted for distal extension.According to the report, the physician was unable to determine if the false lumen perfusion was resolved at the conclusion of the procedure.Reportedly, the physician will continue to monitor the patient.The patient was reported to have tolerated the procedure.

• Brand Name: CONFORMABLE 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7478392
• MDR Text Key: 107067657
• Report Number: 2017233-2018-00251
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Catalogue Number: TGU343415
• Device Lot Number: 15844816
• 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: 11/16/2016
• 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: 82 YR
• Patient Weight: 50