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	TGMR313120
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient medications: not available due to patient being an urgent case.
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment for an acute thoracic aortic dissection using a gore® tag® conformable thoracic stent graft with active control system (ctag-ac).It was reported that the ctag-ac device was introduced through a 20fr sheath and placed in the distal thoracic aortic artery above the celiac artery.When the primary deployment handle was pulled back, the suture broke, the physician then attempted to utilize the back up hatch, line number one.The deployment line snapped/broke again.The device was not deployed through these attempts.The device was removed with the delivery catheter through the sheath and will be returned to gore for evaluation.A two different ctag-ac device's were used for the procedure.There was no further issues and no serious injury to the patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
Correction h3.Device was returned to manufacturer.Addition the device was returned to gore for evaluation.The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the primary deployment line was switched with a steering fiber, such that the primary deployment handle was connected to an angulation fiber, and the primary deployment line (pdl) was connected to the angulation assembly handle.The stent graft of the returned device remained completely constrained.The findings of the evaluation are consistent with the reported event description that primary deployment was unable to be initiated via the primary deployment handle and the deployment line access hatch.The inability to deploy the primary sleeve can be attributed to mis-assembly of the primary deployment handle with an angulation fiber during manufacturing, such that the pdl was not correctly attached to the primary deployment handle.

• 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: 10856870
• Report Number: 2017233-2020-01451
• Device Sequence Number: 19875944
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 04/05/2022
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Weight: 86