MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGMR404010
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented emergently for treatment of a thoracic aortic aneurysm.The physician chose to treat using a frozen elephant trunk procedure, (off label).The gore® tag® conformable thoracic stent graft with active control system was implanted, but when the physician attempted to deploy the device, the deployment wire broke.The physician had to cut down in order to cut, and remove the wire.The patient tolerated the procedure.The device will be returned for evaluation.The physician had no opinion regarding the cause of the breakage.
Additional Manufacturer Narrative
H1/h2: this event was erroneously reported as a reportable malfunction.The event is a serious injury.
Additional Manufacturer Narrative
Gr/g4; added pma/510k number p040043.
Additional Manufacturer Narrative
The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: - the lockwire was separated from the lockwire handle, and the lockwire connector was plastically deformed.Graft material, angulation fiber pieces, and lockwire were identified at the distal transition of the device.- the catheter was cut proximal to the delivery handle.- the angulation assembly handle was incorrectly positioned facing the flushing port and was unable to be removed from the handle assembly.The reported event description did not include any observations regarding the angulation assembly handle.The findings of this evaluation confirmed the lockwire was broken from handle.There was no indication of any damage or manufacturing anomaly that could relate to the lockwire breaking from the handle connector.The reported inability to remove the lockwire, requiring it to be cut, could not be confirmed.Based on the event description and device evaluation, per md145952 rev.20, no manufacturing deficiencies were identified for the broken lockwire and no capa request is required.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10730518
• Report Number: 2017233-2020-01378
• Device Sequence Number: 1114378
• Product Code: MIH
• UDI-Device Identifier: 00733132646838
• UDI-Public: 00733132646838
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2021

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: 04/09/2023
• Device Model Number: TGMR404010
• Device Catalogue Number: TGMR404010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 09/28/2020; 09/28/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 02/01/2021; 03/10/2021; 03/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR