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

Catalog Number TGU373720J

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Rupture (2208)

Event Date 08/26/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Per the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis instructions may include but are not limited to aortic rupture and death.Manufacturing evaluation performed.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Event Description

In 2014, the patient underwent an open ascending aorta and aortic arch replacement with a vascular graft to repair a type a aortic dissection that extended to descending thoracic aorta.On (b)(6) 2015, the patient underwent an endovascular repair of the remaining dissection in descending thoracic aorta using two conformable gore® tag® thoracic endoprostheses ((b)(4) proximal and (b)(4) distal).After the successful implantation of the devices, touch-up ballooning using a coda balloon was performed on the proximal neck and the device junction area.No endoleak was identified, and the procedure was completed with no complications.On (b)(6) 2015, a rupture of the false lumen was identified.The patient expired on the same day from the rupture.The physician reportedly suspected that the aortic wall was damaged at the anastomotic site of the vascular graft due to ballooning of the proximal neck, which led to the false lumen perfusion and the rupture.

• 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: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5059777
• MDR Text Key: 25107068
• Report Number: 2017233-2015-00588
• 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
• Reporter Occupation: Physician
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2018
• Device Catalogue Number: TGU373720J
• Device Lot Number: 13951149
• 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: 06/08/2015
• 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): Death; Life Threatening
• Patient Age: 64 YR