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

Device Problem Mechanical Problem (1384)

Patient Problem Aortic Dissection (2491)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

Patient medications: not available due to patient being an urgent case.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 217673084
• Report Number: 2017233-2020-01451
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (y/n): N
• PMA/PMN Number: PO40043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 02/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 86