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

Model Number	TGU373715
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #tgu373720/ serial #(b)(4) / udi #(b)(4).Additional adverse events for this patient have been investigated and reported under the following manufacturer report numbers: report #2017233-2019-00325 and report #2017233-2019-00499.Concomitant medical products and therapy dates: amlodipine 10mg, aspirin 81mg, atorvastatin 10mg, ferrous sulfate 325mg, hydralazine 50mg, iabetalol 200mg, metformin 500mg, prednisone 20mg, valsartan 160mg.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, persistent false lumen flow, and reoperation.The safety and effectiveness of the gore® tag® thoracic endoprosthesis have not been evaluated in patient etiologies including, but not limited to, chronic type b dissections and previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2015 the patient underwent treatment of a 60 mm descending thoracic aortic aneurysm of chronic type b dissection etiology whereby two conformable gore® tag® thoracic endoprostheses were implanted in zone 3 of the proximal descending thoracic aorta.The patient tolerated the procedure.On (b)(6) 2017 the patient underwent cerebral debranching of the ascending aorta due to a type b dissection.On (b)(6) 2017 a type a aortic dissection was reported.It is unknown whether this dissection was new, or a continuation of the type b dissection.The dissection was treated by means of open repair and replacement of the ascending aorta through a re-do sternotomy.On (b)(6) 2020 aneurysmal degeneration of the type a aortic dissection with enlarged paravisceral aorta was reported.It was reported that the aortic dissection had dilated over time and the patient had a type iv thoracoabdominal aneurysm with dissection of the bilateral renal arteries and multiple fenestration causing false lumen expansion.It was noted that the patient possessed multiple comorbidities.Total endovascular repair of the thoracoabdominal extent for aneurysmal degeneration of the aorta was performed using a 4-vessel backtable fenestration.Gore® excluder® aaa endoprostheses were placed infrarenal for additional seal.Treatment of the right renal artery dissection was performed using coil embolization of the false lumen and extension into the true lumen.Treatment of the left renal artery dissection was performed using extension of the bare metal stent into the kidney hilum, and a cover stent of the true lumen.An endograft was deployed into the previous conformable gore® tag® thoracic endoprostheses with subsequent cannulation and stenting of 4 vessels.A cook medical zenith® tx2®graft, a boston scientific stent express® ld system, two terumo medical coil embolization azur® coils, four gore® viabahn® vbx balloon expandable endoprostheses, and the gore® excluder® aaa endoprostheses were used to complete the procedure.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, persistent false lumen flow, and reoperation.The safety and effectiveness of the gore® tag® thoracic endoprosthesis have not been evaluated in patient etiologies including, but not limited to, chronic type b dissections and previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.The original ifu statement inadvertently referenced the gore® tag® conformable thoracic stent graft with active control system and was corrected to reference the conformable gore® tag® thoracic endoprosthesis.
Additional Manufacturer Narrative
G.2.Report source - corrected/updated from company representative to study.

• Brand Name: CONFORMABLE GORE TAGTHORACIC 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
• MDR Report Key: 12125392
• Report Number: 2017233-2021-02135
• Device Sequence Number: 17026564
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2021

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: 03/31/2018
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021; 07/08/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/06/2021; 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 123