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 TGMR404015E

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

Patient Problem Paresis (1998)

Event Date 12/05/2020

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2020, a patient presenting with an unknown condition was treated with a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2020, the patient presented with transient hemiparesis (grade 3, severe) on the left side.The patient recovered and was discharged on (b)(6) 2020 without treatment.

Manufacturer Narrative

H6-b13: a request was emailed to the initial reporter to clarify the application, the hospital, the physician´s contact, and the dates.H6-b15: gore reviewed a filled serious adverse event report form was provided by leonresearch driving non-gore study "conforta".H6-b20 and h3: the device remains implanted therefore a device evaluation could not be performed.B6-b14: the manufacturing records are being reviewed.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

It was reported that on (b)(6) 2020, a patient presenting with an unknown condition was treated with a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2020, the patient presented with transient hemiparesis on the left side.The hemiparesis resolved without treatment.The patient was discharged on (b)(6) 2020.

Manufacturer Narrative

Cause investigation and conclusion a request was emailed to the initial reporter to clarify the application, the hospital, the physician´s contact, and the dates.The request remains unanswered.A review of the manufacturing records indicated the lot met all pre-release specifications.The device remains implanted therefore a device evaluation could not be performed.Based on the review of the serious adverse event report form provided by leonresearch driving non-gore study "conforta" and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.In the instruction for use (ifu) the following is stated: adverse events potential device or procedure-related adverse events adverse events which may require intervention and/or conversion to open repair include, but are not limited to: - paraplegia/paraparesis.

Manufacturer Narrative

Added physician name to section e.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17260092
• MDR Text Key: 318581993
• Report Number: 2017233-2023-04089
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

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 Expiration Date: 12/25/2021
• Device Catalogue Number: TGMR404015E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 12/07/2023
• Supplement Dates FDA Received: 07/14/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 65 KG