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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	08/31/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022, this patient presented emergently for treatment of a contained rupture of a zone 0 ascending aortic thoracic aneurysm.The physician decided that best course of action was to open the chest and tie a bifurcated graft from the ascending aorta into the innominate and left carotid and then place an endograft to seal the rupture.After the physician had sewed in a bifurcated graft to the head vessels, he was unable to control the bleeding and decided to implant a gore® tag® conformable thoracic stent graft with active control system (ctag ac) in an antegrade fashion under direct visualization.The aorta was punctured with an 18 gauge needle and a 260cmx.035 glide wire was advanced, and a 90cm bernstein catheter was introduced and a wire exchange was preformed exchanging the glide wire for a lunderquist® 260cmx.035 stiff wire.A gore® dryseal flex introducer sheath (dsf) was advanced 1cm into the aorta and then ctag ac was advanced through the dsf and deployed.There was still bleeding so a second ctag ac was deployed and then ballooned.The physician was still unable to control the bleeding and the decision was made to end their attempts to save the patient.Time of death was called.The physician did not state a cause of death and reports all devices performed as intended with no issues.
Additional Manufacturer Narrative
As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: tgm454515/22346742, udi: (b)(4).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15407471
• Report Number: 2017233-2022-03309
• Device Sequence Number: 20211864
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 04/18/2025
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Female