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

Model Number	TGU373715
Medical Device Problem Codes	Entrapment of Device (1212); Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Aortic Dissection (2491); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that on (b)(6) 2019, the patient presented with a dissection of the thoracic aorta.The patient had previously had a thoracic endoprosthesis implanted to treat a dissection of the thoracic aorta, and the dissection of (b)(6) 2019 was distal to this original graft.In addition, the patient had previously been treated for an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.Patient anatomy was reported to be tortuous, and the previously-implanted devices had changed the morphology of the aorta and resulted in increased stiffness of the vessel.When inserting the conformable gore® tag® thoracic endoprosthesis through a 24fr sheath, the physician was unable to advance the sheath past the previously implanted excluder to reach the dissection that was distal to the originally implanted thoracic endoprosthesis.The physician attempted to remove the sheath and device, as it was covering the celiac and renal arteries.They tried again to advance the sheath, without success.It became stuck in the previously implanted excluder device.In the process, the tag device was inadvertently deployed, extending from the common to external iliac artery.The olive was removed from the tag device.A guidewire was used to cannulate the insertion path to move beyond the tag device in order to prepare to trap the olive.The guidewire was removed, and the tag device was ballooned to trap the olive.A competitor's device was used to bridge the dissection in the thoracic aorta.The patient was reported to tolerate the procedure.The physician believed that the cause of the event was tortuousity of the patient anatomy, combined with the previously-implanted devices, which caused additional stiffness in the aorta.
Additional Manufacturer Narrative
H6: method code - code 4117 replaced with code 10 following return of device for evaluation.H6: conclusions code - replaced code 11 with code 61 following results of engineering evaluation.
Event or Problem Description
The device was returned for evaluation.The engineering evaluation stated: there is no leading olive attached to the leading end of the catheter.The stiffening wire remained within the delivery catheter.The delivery catheter near the expected location of the olive demonstrates characteristics of a tensile failure, which is consistent with the event description that the leading olive detached.The deployment lines remained within the delivery catheter and measured approximately 127.6 cm; consistent with lengths expected for this device size.No damage was observed.The trailing olive leash line hole indicates damage consistent with a trailing leash line being forcefully removed.The root cause for the leading olive break is a tensile break due to resistive force.The source of resistive force is unknown but potentially caused by tortuous anatomy or previously implanted devices.

• 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: 9362182
• Report Number: 2017233-2019-01172
• Device Sequence Number: 13995076
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Device Lot Number: 17919030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: Required Intervention
• Patient Age: 84 YR