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 TGM212110J

Device Problem Migration (4003)

Patient Problem Ruptured Aneurysm (4436)

Event Date 04/13/2024

Event Type  Death  

Event Description

On (b)(6) 2024, this patient underwent an endovascular treatment for thoracic aortic aneurysm rupture using gore® tag® conformable thoracic stent graft with active control system (ctag ac).The ruptured site was unknown but four devices were planned to be placed from the descending aorta to aortic arch.The first ctag ac (tgm212110j) was implanted most distal.It was undersized to the aortic diameter (24 mm), so it migrated distally after deployment.The physician attempted to correct the positioning of the device using a gore® molding & occlusion balloon catheter.At that time, blood pressure decreased and aortic re-rupture was suspected.The patient¿s blood pressure did not improve and he died during the procedure.

Manufacturer Narrative

H3: code "other" was selected as the medical devices not available for return.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

B4: event description has been updated to capture the additional information.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: codes for investigation findings and investigation conclusions have been updated to reflect results of investigation.H6: code d12: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft include, but are not limited to: aortic rupture.

Event Description

On april 13, 2024, this patient underwent an emergency endovascular treatment for thoracic aortic aneurysm rupture using gore® tag® conformable thoracic stent graft with active control system (ctag ac).The exact ruptured site was unknown but four devices were planned to be placed from the descending aorta to aortic arch.The first ctag ac (tgm212110j) was implanted most distal.It was undersized to the aortic diameter (24 mm), so it migrated distally after deployment.The physician attempted to correct the positioning of the device using a gore® molding & occlusion balloon catheter.At that time, blood pressure decreased and aortic re-rupture was suspected.The patient¿s blood pressure did not improve and he died during the procedure.Reportedly, this procedure was emergency and thus, available devices were limited and the undersized ctag ac was unavoidably used.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19177805
• MDR Text Key: 340998938
• Report Number: 2017233-2024-04867
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: TGM212110J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male