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

Model Number TSB121506A

Device Problems Loss of or Failure to Bond (1068); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2022

Event Type  malfunction  

Event Description

On (b)(6), 2022, the patient underwent emergency treatment of a symptomatic zone 0 dissecting aneurysm using gore® tag® thoracic branch endoprostheses (tbe).It was reported that a 6fr.Non-gore cook medical introducer sheath was used for right brachial access, and a through-and-through wire was placed for distal access at the patient's femoral artery.The aortic component was implanted with no reported issues and the side branch component was advanced.The patient's anatomy was reported to be extensively tortuous.As deployment of the side branch device was initiated, resistance was reported.It was observed that the dilator of the cook medical introducer sheath had not been retracted and the leading edge of the dilator was wedged between the device.The physician pulled the delivery catheter and the device separated from the introducer sheath.After deployment was successfully completed, the delivery catheter was removed and it was observed that the leading olive tip was not attached.The leading olive tip was observed on the through-and-through wire.A balloon was advanced to the device portal via brachial access and the leading olive tip was pushed distally until it exited the 26fr.Gore® dryseal flex introducer sheath.The issue was reportedly related to the cook medical sheath dilator not being pulled back.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

Age at the time of event/date of birth: asked but unavailable.Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Concomitant medical products and therapy dates: asked but unavailable.Type of investigation: the device remains implanted, and the delivery catheter was discarded at the facility.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.Investigation findings: the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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.

Manufacturer Narrative

Investigation findings: code c19 - an analysis of relevant data was performed in view of supporting the identification of possible causes of the event.The engineering evaluation concluded the following: no device evaluation could be performed as the device was not returned.Per the manufacturing product history record review, a review of the manufacturing records indicated that the lot met all pre-release specifications and none of the quality items identified were related to the reported event.No images were provided for an imaging evaluation.The reason for olive tip detachment could not be determined with the currently available information.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), if a sheath is used from the arm to assist in the delivery of the side branch device, it should be 5fr.Or larger.In this case, the non-gore introducer sheath used was 6fr.And the dilator tip was likely less than 5fr.Therefore, there is potential that, since the dilator was not retracted prior to tracking the side branch to the leading end of the sheath, the dilator tip became embedded between the leading olive tip and the guidewire.It is possible that the force required to separate these ¿wedged¿ devices caused additional force to be applied to the olive tip and subsequently contributed to the olive tip detachment.While this event may be due to the dilator not being removed from the sheath, and engagement of the side branch device with the dilator tip which was likely smaller than the recommended 5 fr., since the device was not returned this root cause could not be confirmed.H.6.Investigation conclusions: code d12 and code d1002 added according to the gore® tag® thoracic branch endoprosthesis ifu, to prevent prolapsing of the side branch (sb) guide wire, advance a sheath or catheter from the brachial or axillary access site.Advance the catheter or sheath from the brachial access site to engage the tip of the sb component to ease introduction of the sb component through the internal portal and into the left subclavian artery.Note: catheter or sheath must be greater than 4 fr.To prevent tip from sliding under sb component olive.If through-and-through wire access is obtained, ensure the vessel size and morphology is adequate for side branch wire manipulation using appropriate vascular access techniques.Furthermore, the ifu states that potential adverse events and complications that may occur with the use of the gore® tag® thoracic branch endoprosthesis include, but are not limited to, insertion or removal difficulty and catheter breakage.H6: investigation findings: code c21 updated to code c19.H6: investigation conclusions: code d16 updated to code d15.

Manufacturer Narrative

H6: investigation conclusions.Code d15: cause not established is removed.Code d1002: adverse event related to procedure is changed to code d1102: unintended use error caused or contributed to event.

• 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: 15583145
• MDR Text Key: 304532752
• Report Number: 2017233-2022-03392
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132654406
• UDI-Public: 00733132654406
• 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,Followup
• Report Date: 02/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TSB121506A
• Device Catalogue Number: TSB121506A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/25/2022; 02/15/2023
• Supplement Dates FDA Received: 11/28/2022; 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 Sex: Male