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	Aneurysm (1708)
Date of Event	10/25/2017
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, report #2017233-2019-00499, report #2017233-2021-02135.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 conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, endoleak, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), and reoperation.
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 a left upper extremity angiogram performed via percutaneous access of the left radial artery.It was reported that the patient's left subclavian artery (lsa), left axillary artery, and left vertebral artery were patent.Antegrade flow was observed directly from the aortic arch into the lsa.Reportedly there was no coverage of the lsa by the implanted devices.A large proximal type i endoleak of the thoracic aorta into the aneurysm sac was observed.No distal type i endoleak was present.Aneurysm enlargement (amount unknown) was also reported.The proximal type i endoleak was reportedly due to aneurysmal degeneration.The physician suggested that proximalization of the graft would be required.There were no further reported issues.The patient tolerated the procedure and was discharged on (b)(6) 2017.
Additional Manufacturer Narrative
B.5.Additional event description added.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® thoracic endoprosthesis include, but are not limited to, endoleak, aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion), and reoperation.H.6.Investigation conclusions: code 11 updated to code 4315.
Event or Problem Description
Additional information was received that proximalization of the graft, as suggested by the physician, has not been performed.

• 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: 12139979
• Report Number: 2017233-2021-02152
• Device Sequence Number: 4180241
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 06/10/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 123