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

Catalog Number TSB081206A

Device Problem Improper or Incorrect Procedure or Method (2017)

Event Date 11/22/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient underwent endovascular treatment of an ascending thoracic aortic dissection using gore® tag® thoracic branch endoprostheses (tbe).The entry tear was observed in the aortic arch at the level of the distal anastomosis proximal to the patient's left subclavian artery (lsa).The length from the distal border of the lsa to the beginning of the entry tear was approximately 2.7cm by outer curve length.A thoracic aortic component and a side branch component were implanted.A proximal type i endoleak was observed on the aortic component, so an aortic extender component was implanted to treat the endoleak.The endoleak remained, so the physician opted to reline the tbe system with a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).The side branch portal was intentionally covered and a vbx device was used to extend from the side branch distally in a periscope technique.The distal end of the vbx device was landed approximately 1.3cm from the distal end of the ctag a/c device.On (b)(6) 2023, the gore representative became aware of follow-up ct imaging which reportedly revealed a distal type i endoleak and suspected gutter leak from the vbx and ctag a/c device.On (b)(6) 2023, the patient underwent reintervention of the endoleaks.An additional ctag a/c was implanted.It was reported that the distal end of the newly implanted ctag a/c device extended passed the initial ctag a/c device.The endoleaks were resolved.Pre-implantation cta dated (b)(6) 2023, and post-implantation cta dated (b)(6) 2023, were provided to gore for evaluation.The imaging evaluation showed contrast in the false lumen perfusing from the level of the lsa.The ctag a/c device, tbe aortic component, and tbe aortic extender component appeared to have adequate overlap and appeared to cover the area where the contrast origin perfusing the false lumen was questionable, thereby, excluding them from a type i endoleak.However, the vbx device, used to extend the tbe side branch component distally, did not overlap with the proximal end of the side branch component as is extends into the lsa.The distal end of the vbx device was landed approximately 1.3cm from the distal end of the ctag a/c device.This finding suggested that the contrast outside the implanted devices at the level of the lsa may have been originating from a possible gutter leak involving the side branch component.

Manufacturer Narrative

Additional devices included on this report are as follows: gore® viabahn® vbx balloon expandable endoprosthesis catalog #unk/ serial #unk/ udi #unk which is captured in manufacturer report #2017233-2024-04534.Catalog #tgmr373710/ serial #(b)(6)/ udi #(b)(4) which is captured in manufacturer report #2017233-2024-04542.A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.C.1.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.H.6.Investigation findings for imaging evaluation: code c19 - two time-points were available for evaluation: pre-implantation cta dated (b)(6) 2023, and post-implantation cta dated (b)(6) 2023.The imaging evaluation, performed by a clinical imaging specialist, showed contrast in the false lumen perfusing from the level of the left subclavian artery (lsa).The ctag a/c device, tbe aortic component, and tbe aortic extender component appeared to have adequate overlap and appeared to cover the area where the contrast origin perfusing the false lumen was questionable, thereby, excluding them from a type i endoleak.However, the vbx device used to extend the tbe side branch component distally did not overlap with the proximal end of the side branch component as is extends into the lsa.The distal end of the vbx device was landed approximately 1.3cm from the distal end of the ctag a/c device.This finding may suggest that the contrast outside the implanted devices at the level of the lsa may be originating from a possible gutter leak involving the side branch component.The endoleak persists on the last time-point available for evaluation.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.

Event Description

On (b)(6) 2023, the patient underwent endovascular treatment of an ascending thoracic aortic dissection using gore® tag® thoracic branch endoprostheses (tbe).The entry tear was observed in the aortic arch at the level of the distal anastomosis proximal to the patient's left subclavian artery (lsa).The length from the distal border of the lsa to the beginning of the entry tear was approximately 27mm by outer curve length.A thoracic aortic component (tac083415) and a side branch component (tsb081206) were implanted.The proximal segment length on the tac083415 is 20mm and, therefore, landed in dissected tissue and did not cover the primary entry tear.The physician extended proximally with an aortic extender component (te3742).There was insufficient overlap between the aortic extender and aortic component leading to a type iii endoleak.To treat this endoleak, the physician opted to reline the tbe system with a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).The proximal end of the ctag a/c was within the aortic extender.The side branch (sb) portal was intentionally covered and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was used to extend from the side branch distally in a periscope technique.The distal end of the vbx device was landed approximately 1.3cm from the distal end of the ctag a/c device.On (b)(6) 2023, follow-up ct imaging revealed an endoleak and suspected gutter leak from the vbx and ctag a/c device.On december 12, 2023, the gore representative became aware of the endoleak event.On (b)(6) 2023, the patient underwent reintervention for the endoleak.An additional ctag a/c was implanted within the existing ctag a/c.It was reported that the distal end of the newly implanted ctag a/c device extended passed the initial ctag a/c device to intentionally cover and collapse the distal end of the previously implanted vbx sb extension.The endoleak was resolved and the physician bypassed the lsa to the left common carotid artery to maintain flow.A post-implantation cta dated (b)(6) 2023, was provided to gore for evaluation and showed contrast in the false lumen perfusing from the level of the lsa.The ctag a/c device, tbe aortic component, and tbe aortic extender component appeared to have adequate overlap and appeared to cover the area where the contrast origin perfusing the false lumen was questionable.This finding excluded the devices from a type i endoleak.However, the vbx device, used to extend the tbe side branch component distally, did not fully reline the side branch component proximally where the side branch component extends into the lsa.This finding suggested that the contrast outside the implanted devices at the level of the lsa may have been originating from a possible gutter leak involving the side branch component.The origin of the endoleak remains indeterminate.

Manufacturer Narrative

Additional devices included on this report are as follows: gore® viabahn® vbx balloon expandable endoprosthesis catalog #unk/ serial #unk/ udi #unk which is captured in manufacturer report #2017233-2024-04534.Catalog #tgmr373710/ serial # (b)(6)/ udi # (b)(4) which is captured in manufacturer report #2017233-2024-04542.Catalog #tac083415a/ serial # (b)(6)/ udi # (b)(4) as the same device family.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), potential adverse events and complications that may occur with the use of the gore® tag® thoracic branch endoprosthesis include, but are not limited to, endoleak, persistent false lumen flow, and reoperation.Additionally, the ifu states that the gore® tag® thoracic branch endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who have an appropriate proximal aortic landing zone.For dissection patients, the primary entry tear must be distal to the left subclavian artery and the proximal extent of the landing zone must not be dissected.B.3.Date of event corrected: as the endoleak was identified on follow-up imaging dated (b)(6) 2023, the date of event has been corrected.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• Brand Name: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
• Type of Device: 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18784095
• MDR Text Key: 336290297
• Report Number: 2017233-2024-04659
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P210032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TSB081206A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male