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

Model Number	TGU454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: tgu454510/16459996, udi: (b)(4).According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: vascular spasm or vascular trauma (e.G., ilio-femoral vessel dissection, bleeding, rupture) a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for a thoracoabdominal aneurysm and was implanted with two conformable gore® tag® thoracic endoprostheses in the descending thoracic aorta.The patient tolerated the procedure.On an unknown date in (b)(6) 2020, the patient underwent endovascular treatment and was implanted with cook zenith fenestrated endovascular (zfen) device and zenith alpha abdominal endovascular grafts within the abdominal aorta.The patient tolerated the procedure.On (b)(6) 2020, this patient underwent emergent treatment for a ruptured thoracoabdominal aneurysm distal to the conformable gore® tag® thoracic endoprostheses in the area of the gap from the abdominal devices.An unknown endoleak in the distal aorta was suspected but was unable to be confirmed.A conformable gore® tag® thoracic endoprostheses was advanced via a gore® dryseal flex introducer sheath however the sheath was unable to be advanced to the intended location due to the small diameter of the patient¿s femoral arteries.The sheath and undeployed device were withdrawn and two gore® excluder® aaa aortic extender endoprosthesis were implanted instead to treat the rupture.The patient tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10029765
• Report Number: 2017233-2020-00321
• Device Sequence Number: 3816928
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2020
• Device Model Number: TGU454520
• Device Catalogue Number: TGU454520
• Device Lot Number: 16565562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR