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

Catalog Number TGU404015

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Death (1802); Rupture (2208); Aortic Dissection (2491); Blood Loss (2597); Vascular Dissection (3160)

Event Date 09/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Udi info: (b)(4).Results: the review of the manufacturing records for the device verified that this lot met all pre-release specifications.Results: an imaging evaluation is currently in progress.Conclusion: according to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to bleeding and death.

Event Description

On (b)(6) 2017 a patient underwent treatment for penetrating atherosclerotic ulcer of the thoracic aorta with a gore® tag® thoracic endoprosthesis.The device was placed at the level of the left common carotid artery, proximally.A left subclavian bypass was also performed.The procedure went well and the final angiographic run was reportedly satisfactory.On (b)(6) 2017, the patient was bradycardic.A ct showed a retrograde type a dissection.The patient was taken to surgery where it was found the dissection had ruptured and bled into the pericardium.The patient expired during the procedure.

Manufacturer Narrative

Updated.Results: the imaging evaluation stated the following: one time point available for evaluation; pre-implantation cta dated (b)(6) 2017.The patient presents with a bovine arch.The length from the lsa to the lesion appears to be ~2.3cm, by outer curve length.The length of the lesion appears to be approximately 4.6cm, by outer curve length.Images provided do not allow for evaluation in relationship to this event.

Event Description

On (b)(6) 2017 a patient underwent treatment for penetrating atherosclerotic ulcer of the thoracic aorta with a conformable gore® tag® thoracic endoprosthesis.The device was placed at the level of the left common carotid artery, proximally.A left subclavian bypass was also performed.The procedure went well and the final angiographic run was reportedly satisfactory.On (b)(6) 2017, the patient was bradycardic.A ct showed a retrograde type a dissection.The patient was taken to surgery where it was found the dissection had ruptured and bled into the pericardium.The patient expired during the procedure.

• 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 MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6881194
• MDR Text Key: 86836236
• Report Number: 2017233-2017-00488
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/22/2017

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: 07/26/2019
• Device Catalogue Number: TGU404015
• Device Lot Number: 15419424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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): Death
• Patient Age: 84 YR