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	TGM262610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and delivery catheter were returned to gore for evaluation.The evaluation showed the following: the primary deployment line (pdl) was broken after the slip knots were undone at the proximal end of the device but prior to the device starting to deploy.The woven deployment line loop and slip knots were undone but the stitches of the primary deployment sleeve were entirely intact.This resulted in the primary sleeve deployment not being initiated.The break surface on the broken fiber appears to have characteristics of a mostly cut surface as well as potentially a small tensile failure.Additional damage was identified at the proximal end of the device on the primary sleeve reinforcement line.The findings of the evaluation are consistent with the physician¿s observation that the device did not deploy following the initiation of primary deployment.The reason for the primary sleeve deployment not being initiated is that the primary deployment line broke after the slip knots were undone at the proximal end of the device but prior to the device starting to deploy.
Event or Problem Description
On (b)(6) 2020, during an endovascular treatment of a thoracic aortic aneurysm using a gore® tag® thoracic endoprosthesis, it was reported that the deployment knob seemed to "snap off and nothing happened".The device did not deploy.The physician was able to pull the device back into the sheath and remove the device from the patient.Another device was then used successfully.Upon removal of the device, it was noted that there appeared to be frayed deployment lines at the leading end of the delivery catheter.

• 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: 12356043
• Report Number: 2017233-2021-02300
• Device Sequence Number: 19967390
• Product Code: MIH
• UDI-Device Identifier: 00733132646920
• UDI-Public: 00733132646920
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 06/02/2023
• Device Model Number: TGM262610
• Device Catalogue Number: TGM262610
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR