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

Catalog Number TGU343415

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

Patient Problem Not Applicable (3189)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, the patient was implanted with a conformable gore® tag® thoracic endoprosthesis (tgu454515/20336442).A carotid subclavian bypass was also done and a 14 mm & 12 mm amplatzer plug was placed in the left subclavian ostium above the graft and the graft was deployed at the bovine arch.It was reported no spinal drain was placed but neuro monitoring was done.The patient was moving legs following the procedure.The physician was called the next day and the patient was presenting with paralysis.A spinal drain was put in to relieve symptoms and the hospital is working the patient through rehab.The event is ongoing.

Manufacturer Narrative

Correction: a2.Addition it was reported on (b)(6), 2019, that the patient went to rehab, and is walking again, and everything subsided.No further information was available.

• 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: 9082985
• MDR Text Key: 161927020
• Report Number: 2017233-2019-00872
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• 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: 10/30/2019

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: 10/11/2021
• Device Catalogue Number: TGU343415
• Device Lot Number: 18826439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR