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

Catalog Number TAC083715A

Device Problem Positioning Failure (1158)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

This event also includes device 27473787/ 00733132654321.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

Fsa reported: "following ivus assessment of the aortic arch and access a dsf 2465 was placed in a standard manner over a lunderquist double curve wire.The first te37 was advanced without resistance.A parallel wire and flush catheter was advanced and angiographic imaging was performed.The cuff was deployed with the ¿bare¿ proximal stent partially across the left carotid artery.Upon retracting the te catheter it appeared that the te moved distal approx.3-5mm to the distal margin of the left carotid.Angiography was performed and there appeared to be a persistence type 1a.Ballooning with the large trilobe was performed.Repeat angiography appeared to row residual, but possibly reduced, type 1a endoleak.The flush catheter was removed and a second te37 was advanced and deployed with the ¿bare¿ proximal stent across the left carotid artery, following repeat angiography.Upon removal of the delivery catheter it appeared that the second te37 moved distal into approximately the same position as the first te37.Tri-lobe ballooning was performed.Angiography appeared to show persistent, but further reduced, type 1a endoleak.The physician elected to observe the pt and to obtain a follow-up cta prior to discharge.It was reported that the follow-up cta demonstrated a possible residual type 1a endoleak.".

Manufacturer Narrative

H.6.Type of investigation code b21 updated to code b14, b15 with completion of phr review and imaging evaluation.H.6.Investigation findings: code c21 updated to code c19 with completion of phr review and imaging evaluation.H.6.Investigation conclusions: code d16 updated to code d15 and d12 according to the gore® tag® thoracic branch endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak.An imaging evaluation was performed.The investigation stated: the imaging evaluation performed by a clinical imaging specialist showed the following: two post-implantation cta scans dated 5/01/2023 received for evaluation.Post-implantation chest cta and abdomen/pelvis cta.Axial imaging shows contrast outside the proximal implanted thoracic aortic device and the side branch in the lsa.Thereby, confirming a proximal type i endoleak.There appears to be an aortic tear near the lsa origin.Flow is perfusing the false lumen past the level of the sma.The sma is dissected.The proximal circumferential thoracic aortic device is ~20mm distal to the distal border of the lcca.Length from the distal border of the lsa to the proximal circumferential device appears to be 20.9mm, by outer curve length.There appears to be a portion of proximal bare stent, proximal to the distal border of the lcca origin.The length from the proximal bare stent to the distal border of the lcca appears to be ~4.7mm, by outer curve length.Thoracic aortic diameter at the proximal circumferential device appears to be 37.4mm.Thoracic aortic diameter at the distal border of the lsa appears to be 40.1mm.Reconstruction image shows the presence of at least one ctag in the dta, a gore® tag® thoracic branch endoprosthesis in the arch, and a side branch device in the lsa.

Manufacturer Narrative

G3/g4 510(k)/pma number corrected to p210032.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18222135
• MDR Text Key: 329194554
• Report Number: 2017233-2023-04435
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132654116
• UDI-Public: 00733132654116
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/29/2024

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: TAC083715A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/05/2023; 11/05/2023
• Supplement Dates FDA Received: 12/13/2023; 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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: 65 YR
• Patient Sex: Male