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 TGM343420J

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

As it is not known which device, if either contributed to the event, the following additional device is being investigated: tgu282820j, sn (b)(4), udi: (b)(4).According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and/or require intervention include, but are not limited to: neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).

Event Description

The following was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment of a descending thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system and a gore® tag® conformable thoracic endoprosthesis.An axillary ¿ axillary bypass procedure was performed.Tgm343420j was implanted proximally and tgu282820j was implanted distally.After all devices were implanted, angiography imaging revealed a proximal type i endoleak.Ballooning was performed to the proximal end of tgm343420j, but the endoleak still remained slightly.The physician decided to monitor it.The procedure was concluded.When the patient recovered from anesthesia, the patient was not able to move both lower limbs and had no feeling of both lower limbs.A cerebrospinal fluid drainage was performed to treat it.On (b)(6) 2020, a mild cerebral infarction occurred.The paraplegia continued and the patient was still not able to move both lower limbs.The physician stated that this patient had high risk for the paraplegia because the patient aorta was shaggy and the stent grafts were implanted for long lesion.The physician continues to monitor the patient.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots 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
• MDR Report Key: 10987228
• MDR Text Key: 220910633
• Report Number: 2017233-2020-01521
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 03/05/2023
• Device Catalogue Number: TGM343420J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 89 YR