MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU454520J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Paraplegia (2448)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Additional device: tgmr373720j, lot #: 20959146, udi: (b)(4).

Event Description

The following was reported to gore: on (b)(6) 2019, the patient underwent an endovascular procedure to repair an impending rupture of a descending aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis (tgu454520j/19984225) and a gore® tag® conformable thoracic stent graft with active control (tgmr373720j/20959146).The procedure was completed and the patient tolerated the procedure.On the same day of the procedure, paraplegia was observed.To remedy this, spinal drainage was performed.The patient is being monitored.It was reported that the left external iliac artery rupture was thought to be due to the access vessel being thin and accordion shaped.Reportedly the physician was concerned about paraplegia before the procedure since the patient was observed to have a shaggy aorta.

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.Conclusion code 1: 22: according to the conformable gore tag® thoracic endoprosthesis and gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur include, but is not limited to paralysis.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9527864
• MDR Text Key: 184828678
• Report Number: 2017233-2019-01279
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/28/2019

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: 11/04/2021
• Device Catalogue Number: TGU454520J
• Device Lot Number: 19984225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 85 YR