MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGM454515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/15/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient medical history: open surgical repair of the ascending thoracic aorta with dacron graft approximately one month before treatment of the chronic stanford type b dissection.Additional devices implanted and/or related to this event: tgm454515/20956254, udi (b)(4), tgm454520/21538045 udi (b)(4), tgm454520/21578887 udi (b)(4).
Event or Problem Description
The field sales associate reported the following: on (b)(6) 2020, this patient underwent treatment for a chronic stanford type b dissection with aneurysmal degeneration and was implanted with four gore® tag® conformable thoracic stent grafts with active control system.Coiling and plugging of the false lumen was performed and a knickerbocker technique using a gore® tri-lobe balloon catheter was used to successfully place the first three devices.The physician then changed out the gore® tri-lobe balloon catheter with a 46mm coda® balloon catheter for placement of the fourth device.At this time a rupture of the false lumen was suspected, the patient underwent a blood transfusion and other adjunctive measures without success.The patient expired intraprocedural.There was no allegation of deficiency of any of the gore devices during the procedure.The cause of death is believed to be rupture of the false lumen.
Additional Manufacturer Narrative
H6: code 213- the review of the manufacturing paperwork verified, that these lot/serial numbers met all pre-release specifications.H6: code 22- according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), ¿adverse events that may occur and/or require intervention include, but are not limited to death.
Additional Manufacturer Narrative
Correction: g5 pmga/510(k).

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10228202
• Report Number: 2017233-2020-01013
• Device Sequence Number: 3195034
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020; 06/15/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/11/2020; 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR