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 TGM282815J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 10/01/2023

Event Type  Injury  

Event Description

The following publication was reviewed by gore: title: a case in which aortic intimal sarcoma was diagnosed by tumor biopsy during stent graft implantation and early chemotherapy was performed source: the journal of japanese college of angiology 2023: 63(suppl.) p.S254.48 year old female.She visited the hospital complaining of lower back pain, and a metastatic bone tumor was suspected.A ct-guided biopsy diagnosed her with sarcoma.Contrast-enhanced ct revealed tumorous lesions with wall thickening in the thoracoabdominal aorta and its branch vessels, and aortic intimal sarcoma was suspected.A saccular aneurysm was also observed in the descending thoracic aorta.Stent graft insertion and biopsy of the intravascular neoplastic lesion were performed.Gore tag tgm282815j was deployed using a 22fr dry seal sheath.No endoleak was observed after touch-up.Thereafter, the dry seal sheath was placed near the tumor, and a biopsy was performed using biopsy forceps.After the procedure, the patient developed transient paraplegia, but it improved with blood transfusion, blood pressure control, and steroid pulse therapy, and she was discharged from the hospital on the 5th postoperative day.Postoperative pathology revealed aortic intimal sarcoma, with multiple bone metastases and liver metastases.The patient was admitted to the hospital on the 15th day after procedure, and medication treatment began on the 20th day.Currently, the tumor is not growing and is undergoing chemotherapy.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: a review of the manufacturing records for the device could not be performed as a valid lot number was not provided.H6: 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 device include, but are not limited to: neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).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 publication was reviewed by gore: title: a case in which aortic intimal sarcoma was diagnosed by tumor biopsy during stent graft implantation and early chemotherapy was performed source: the journal of japanese college of angiology 2023: 63(suppl.) p.S254.48 year old female.She visited the hospital complaining of lower back pain, and a metastatic bone tumor was suspected.A ct-guided biopsy diagnosed her with sarcoma.Contrast-enhanced ct revealed tumorous lesions with wall thickening in the thoracoabdominal aorta and its branch vessels, and aortic intimal sarcoma was suspected.A saccular aneurysm was also observed in the descending thoracic aorta.Stent graft insertion and biopsy of the intravascular neoplastic lesion were performed.Gore tag (b)(4) was deployed using a 22fr dry seal sheath.No endoleak was observed after touch-up.Thereafter, the dry seal sheath was placed near the tumor, and a biopsy was performed using biopsy forceps.After the procedure, the patient developed transient paraparesis, but it improved with blood transfusion, blood pressure control, and steroid pulse therapy, and she was discharged from the hospital on the 5th postoperative day.Postoperative pathology revealed aortic intimal sarcoma, with multiple bone metastases and liver metastases.The patient was admitted to the hospital on the 15th day after procedure, and medication treatment began on the 20th day.Currently, the tumor is not growing and is undergoing chemotherapy.

• 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: ayako yoshioka ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18593022
• MDR Text Key: 333897091
• Report Number: 2017233-2024-04568
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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: TGM282815J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/28/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 48 YR
• Patient Sex: Female