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

Catalog Number TGU312610J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Paraplegia (2448)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of a distal aortic arch aneurysm using two conformable gore® tag® thoracic endoprostheses (tgu312610j/14241428 and tgu343415j/14354314).The patient has a ¿bovine arch¿ artery from which the brachiocephalic and left common carotid arteries originates together, and two endoprostheses were successfully deployed distal to the bovine-arch artery.The patient tolerated the procedure.On the same day post initial implant procedure, the patient suffered from paraplegia.Spinal drainage was performed for the paraplegia with the patient¿s blood pressure maintained.The patient is getting recovered from paraplegia.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to neurologic damage, local or systemic (including paraplegia) and reoperation.

• Brand Name: CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7204817
• MDR Text Key: 97710124
• Report Number: 2017233-2018-00031
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2018
• Device Catalogue Number: TGU312610J
• Device Lot Number: 14241428
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TGU343415J/14354314; TGU343415J/14354314
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR