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 TGMR373720J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.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

The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular procedure for an enlarging thoracic aortic pseudoaneurysm which had developed after the aortic arch vascular graft replacement.Gore® tag® conformable thoracic stent graft with active control systems (ctag) were used for the procedure.The right femoral artery was cut down, and a tgmr373720j was delivered.Upon deployment, the device moved distally because the physician was not holding the handle and the shaft of the catheter in a steady manner.The hypotension was noted (approx.Diastolic bp 30~40mmhg), therefore, the physician immediately inserted another ctag (tgm454520j) to the distal end of the tgmr373720j, which recovered and stabilized the blood pressure.(approx.Maximal bp 100mmhg / diastolic bp 60mmhg).After all stent grafts were deployed, a hematoma was noted within the aneurysm at the end of the procedure.It was considered that the tgmr373720j could have damaged the vessel when it moved during deployment, causing the hypotension due to bleeding and subsequent hematoma.No further treatment was provided, and the patient tolerated the procedure.On the same day after the procedure, a proximal type i endoleak was confirmed.On (b)(6) 2023, a reintervention was performed to treat the proximal type i endoleak.An additional ctag was added to the proximal end of the previously implanted stent grafts.The proximal type i endoleak was resolved.The patient tolerated the procedure.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18044756
• MDR Text Key: 327018001
• Report Number: 2017233-2023-04374
• 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: 12/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: TGMR373720J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: 75 YR
• Patient Sex: Female