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

Catalog Number TGU373710J

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

Patient Problems Air Embolism (1697); Infarction, Cerebral (1771)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

Per 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.See also mfg report# 2017233-2020-00099.

Event Description

On (b)(6) 2020, a patient underwent a treatment of thoracic aortic aneurysm with conformable gore® tag® thoracic endoprostheses.After an ax-ax bypass was performed, tgu454515 was placed under the lcca.Then an embolization of the origin of the lsa using coil and plug was performed.Although the procedure was completed without any problem, the patient did not recover from anesthesia.A stroke was suspected and an mri was conducted.The mri revealed a cerebral infarction.The physician suspected a thromboembolism, and an unknown medication was administered.On (b)(6) 2020, the patient was reported to still be unconscious, but was in the icu and breathing spontaneously.The physician now suspects an air embolism.No additional intervention is planned.

Manufacturer Narrative

Method code - code 3331 added for results of manufacturing evaluation code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications code 22 ¿ 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.See also mfg report# 2017233-2020-00099.

• 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: 9716736
• MDR Text Key: 179627409
• Report Number: 2017233-2020-00100
• 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: 03/06/2020

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: 12/09/2021
• Device Catalogue Number: TGU373710J
• Device Lot Number: 20417133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR