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

Catalog Number	TGMR373715
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, patient underwent an endovascular procedure with an initial implant of gore® tag® conformable thoracic stent graft with active control system (sn#(b)(6)) in zone 2 left common carotid (lcc) to treat a type b dissection w/ malperfusion.The ctagac was up to the level of the left common carotid artery with a chimney (gore® viabahn® vbx balloon expandable endoprosthesis 11mmx 39mm) stent in the left subclavian artery (lsa) that resolved the fenestration and the type b dissection.The false lumen was not pressurized.Patient tolerated the procedure.On (b)(6) 2023, the patient underwent a reintervention procedure due to a type 1a endoleak that had fenestration now between the subclavian artery and the previous gore® tag® conformable thoracic stent graft with active control system (sn#(b)(6)) in the descending aorta that was leaking from around the graft and the subclavian artery.The fenestration was between the ctag and lsa stent.It appeared the vbx pulled out of the lsa.They put in three gore® viabahn® vbx balloon expandable endoprosthesis (vbx) first then a gore® excluder® aaa endoprosthesis (sn#(b)(6), pll- iliac extender) to extend distally, which spanned the whole length of the vbx and went more distal in the left subclavian artery.Patient still had the type 1a endoleak.On (b)(6) 2023, the patient was brought back for a third procedure to treat the type 1a endoleak between the ctagac (sn#(b)(6)) and the pll (sn#(b)(6)) with a gutter leak.During the procedure, physician extended proximally with a ctagac (sn#(b)(6)) from the original implanted ctagac (sn#(b)(6)).Then, they did balloon touch ups on the ctagac with the gore® tri-lobe balloon catheter, no ballooning was done in the vbx stents.There was a faint type 1a endoleak after the procedure.Patient tolerated the procedure.The new 40mm ctag and ballooning the aorta diminished the leak into the false lumen.2 weeks after the third procedure (date unknown), a repeated cat scans was done and it showed no type 1a endoleak and looked to be good.Then within 1-2 weeks after the cat scan (date unknown), the patient had a retrograde type a dissection.On (b)(6) 2023, field sales associate was notified on the status of patient passing away by the physician.Physician felt it might have been the chimney stents (gore) that were extended beyond the ctagac graft, it was not extended past innominate (brachiocephalic) artery.Physician was surprised the retrograde dissection started proximal to the innominate artery which was beyond the vbx stent.The vbx stents were distal to where the type b dissection that occurred (which was proximal to the innominate artery), not in the area where the chimney stents were.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Added a4: patient weight.Added b5: describe event or problem and b7: relevant tests/laboratory data, including dates.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to endoleak, dissection, reoperation and death.Added h3 device evaluated by manufacturer: other code - imaging evaluation summary: imaging summary: the imaging evaluation performed by a clinical imaging specialist showed the following: three time points are available for evaluation, pre-implant cta dated on (b)(6) 2023.Post-implant cta¿s dated on (b)(6) 2023.Pre-implant cta dated on (b)(6) 2023 illustrates: o diameters in the 2 cm distal to the lcca range from 33.6 mm ¿36.1 mm.Proximal 17 mm of the lsa appears to be dissected.There is a significant angle present at 3 cm distal to the lsa ostium.Post-implant cta dated on (b)(6) 2023 illustrates: there is a stent graft present on the medial side of the aortic arch, it measures ~ 28 mm in length via centerline reconstruction.The distal end of this stent is proximal to the lsa ostium.There is a lack of wall apposition near the proximal end of the implanted graft.There is contrast outside of the implanted thoracic graft on the arterial and delay phases.Findings are consistent with the reported type 1 endoleak.Post-implant cta dated on (b)(6) 2023 (arterial phase only) illustrates: findings are consistent with the previously visualized and reported type 1 endoleak on cta dated on (b)(6) 2023.There is a stent graft present, proximal end remains in the aortic arch, however, additional stents have been implanted and the stent treatment length now measures ~ 65.4 mm via centerline reconstruction.Distal landing zone of stent is at or near the angle in the lsa.Ascending aorta, proximal to the brachiocephalic appears to be free of dissection and stent grafts.Corrected b3: date of event.
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, patient underwent an endovascular procedure with an initial implant of gore® tag® conformable thoracic stent graft with active control system (sn#: (b)(6) in zone 2 left common carotid (lcc) to treat a type b dissection w/ malperfusion.The ctagac was up to the level of the left common carotid artery with a chimney (gore® viabahn® vbx balloon expandable endoprosthesis -11mmx 39mm) stent in the left subclavian artery (lsa) that resolved the fenestration and the type b dissection.The false lumen was not pressurized.Patient tolerated the procedure.On (b)(6) 2023, the patient underwent a reintervention procedure due to a type 1a endoleak into the fenestration now between the left subclavian artery (vbx chimney stent) and the previous gore® tag® conformable thoracic stent graft with active control system (sn#: (b)(6) in the descending aorta that was leaking from around the graft and the left subclavian artery as it appeared the vbx pulled out of the lsa.They put in three gore® viabahn® vbx balloon expandable endoprosthesis (vbx) first then a gore® excluder® aaa endoprosthesis (sn#: (b)(6), pll- iliac extender) to extend distally, which spanned the whole length of the vbx and went more distal in the left subclavian artery as the vbxs kept pulling back when being inflated and would not make the complex turn of the anatomy.Patient still had the type 1a endoleak.On (b)(6) 2023, the patient was brought back for a third procedure to treat the type 1a endoleak between the ctagac (sn#: (b)(6) and the pll (sn#: (b)(6) with a gutter leak.During the procedure, physician extended proximally with a ctagac (sn#: (b)(6) from the original implanted ctagac (sn#: (b)(6).Then, they did balloon touch ups on the ctagac with the gore® tri-lobe balloon catheter, no ballooning was done in the vbx stents.There was a faint type 1a endoleak after the procedure.Patient tolerated the procedure.The new 40mm ctag and ballooning the aorta diminished the leak into the false lumen.2 weeks after the third procedure (date unknown), a repeated cat scans was done and it showed no type 1a endoleak and looked to be good.Then within 1-2 weeks after the cat scan (date unknown), the patient had a retrograde type a dissection (rtad).On september 26, 2023, field sales associate was notified on the status of patient passing away by the physician.Physician felt it might have been the chimney stents (gore) that were extended beyond the ctagac graft, it was not extended past innominate (brachiocephalic) artery.Physician was surprised the retrograde dissection started proximal to the innominate artery which was beyond the vbx stent.The vbx stents were distal to where the type b dissection that occurred (which was proximal to the innominate artery), not in the area where the chimney stents were.The physician doesn't really know if there is any allegation against the gore device as a cause of death but the ct surgeon who treated the rtad said he thought the ctag might have caused the injury but it was distal to the area of the injury, which occurred in the ascending (proximal to stent and innominate).

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17863288
• Report Number: 2017233-2023-04316
• Device Sequence Number: 17676111
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 02/18/2025
• Device Catalogue Number: TGMR373715
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 64 KG