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

Model Number	TGU404020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Vascular Dissection (3160)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: on (b)(6) 2021, the field sales associate (fsa) was supporting a case to reintervene on a pseudoaneurysm of the proximal anastomosis site of a 24mm infrarenal aortobifemoral surgical graft.The patient is believed to have initially presented in 2017 or 2018 with a type a dissection with extension into the iliac arteries, and had the following procedures prior to the planned reintervention of the proximal anastomosis site: aortic valve and ascending surgical replacement.Redo sternotomy for surgical arch replacement with a 32mm dacron elephant trunk.Placement of a conformable gore® tag® thoracic endoprosthesis (tgu404020/16281848) in the elephant trunk (performed on (b)(6) 2018).At least 2 other conformable gore® tag® thoracic endoprostheses (tgm343415/21013776 and tgmr404015/20998160) were put in distal to the tgu404020 infrarenal aortobifemoral surgical graft.No computed tomography (ct) scan was provided to the fsa prior to the case.During the case on (b)(6) 2021, it was observed on fluoro that there were potential stent fractures in the most proximal conformable gore® tag® thoracic endoprosthesis (tgu404020 stent graft) that was previously placed in the elephant trunk.Following this observation, the patient ct scan was reviewed by the fsa and the physician with fractures of the stent and thrombus in the stent graft identified, with the thrombus potentially due to a type iii endoleak.A foreign body, potentially a stent apex, was also noticed in the patients left common iliac artery.At this point, the plan changed from only reintervention of the proximal anastomosis site of the infrarenal graft, to relining the previous implanted devices.The following was completed: a conformable gore® tag® thoracic endoprosthesis (tgm313120) was placed across the proximal anastomosis site of the infrarenal graft.The conformable gore® tag® thoracic endoprosthesis (tgm313120) was extended proximally with a conformable gore® tag® thoracic endoprosthesis (tgm343415 and a tgm404020).A conformable gore® tag® thoracic endoprosthesis (tgm343410) was placed distal to the first tgm313120 for extended coverage.Following placement of the conformable gore® tag® thoracic endoprostheses, there was no more pulsatile flow observed on the tgu404020 that was identified with stent fractures.Additionally, no endoleaks were observed, the arch and visceral bypasses were all patent, and there was no observed flow in the false lumen.The physician decided to not do any additional interventions on the observed foreign body in the patient¿s left common iliac artery.Following the case, plain film x-rays of the patient from previous years were reviewed.It was noted that the conformable gore® tag® thoracic endoprosthesis stent appeared to be fractured in those previously taken x-rays.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, added h6 health effect-clinical code, health effect-impact code, component code, investigation findings, and conclusion.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12411381
• Report Number: 2017233-2021-02327
• Device Sequence Number: 17237633
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 04/18/2020
• Device Model Number: TGU404020
• Device Catalogue Number: TGU404020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male