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

Catalog Number TGU373720

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The patient referenced in this event file is enrolled in a collaborative society for vascular surgery vascular quality initiative (svs vqi) dissection project.The purpose of this post-approval surveillance, using the svs vqi registry, is to obtain data that can be used to refine the selection of, and treatment strategy for patients with type b aortic dissections managed through endovascular graft repair.Specifically, this surveillance project evaluates the short- and long-term clinical performance of endovascular grafts for the treatment of type b thoracic aortic dissection, following premarket approval.Multiple manufacturers are participating in the svs vqi dissection project and the below information involves a patient treated with an endovascular gore® device.On (b)(6) 2014, this patient underwent emergent endovascular treatment for an acute type b aortic dissection and was implanted with three conformable gore® tag® thoracic endoprostheses, the most proximal device was landed in zone 2 and two additional ctag devices were placed in zone 4, the entry tear was reportedly not covered.The dissection was rapidly expanding and extended from zone 2 to zone 13.The maximum total aortic diameter (including true and false lumen in dissection) within the diseased segment being treated measured 50.8mm at the origin of zone 3.It was reported that the patient suffered an intraprocedure unintentional septal rupture in zone 4.The patient tolerated the procedure without evidence of endoleak.

Manufacturer Narrative

All information contained in this event file was received from the vqi data base.Vqi is not managed, maintained or supervised by gore; or any representative of gore.The initial information obtained from vqi is the only information being provided.Further investigation is not possible as identifiable data as to site(s), physician(s), patient(s), device(s) and/or specific date(s) are not being provided.Please note: the year of implant was provided, however, the exact date of implant is unknown and will be estimated to be (b)(6) 2014.

• 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: laura crawford ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4460821
• MDR Text Key: 16308218
• Report Number: 2017233-2015-00034
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TGU373720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR
• Patient Weight: 93