MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number TGU313110

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem Ischemia (1942)

Event Date 05/11/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for acute type a dissection using a 31mm x 31mm x 10cm conformable gore® tag® thoracic endoprosthesis (ctag).The ctag was advanced through 0.035 boston super stiff wire to descending aorta.The physician didn't feel resistance when pulling deployment line during deployment.After he thought that the deployment line was fully pulled out, he tried to remove the delivery catheter.However, the delivery catheter couldn't be removed.Then it was found that the ctag was partially expanded by x-ray examination.The deployment line was broken when distal end of stent was deployed and proximal part was constrained.The physician used kelly device to shrink the partial expanded ctag to pull it out.Another ctag was used to complete procedure.The procedure was prolonged for about 30mins to remove the ctag.The patient tolerated the procedure and had minor ischemia bowel syndrome within three days after procedure.He has recovered now.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-released specifications.

Event Description

The following was reported to gore: on (b)(6), 2022, the patient underwent endovascular treatment for acute type a dissection using a 31mm x 31mm x 10cm conformable gore® tag® thoracic endoprosthesis (ctag).The patient was open chest.The physicians used frozen elephant trunk technique and planned to implant ctag retrograde.The ctag was advanced through 0.035 boston super stiff wire to descending aorta.The physician didn't feel resistance when pulling deployment line during deployment.After he thought that the deployment line was fully pulled out, he tried to remove the delivery catheter.However, the delivery catheter couldn't be removed.Then it was found that the ctag was partially expanded by x-ray examination.The deployment line was broken when distal end of stent was deployed and proximal part was constrained.The physician used kelly device to shrink the partial expanded ctag to pull it out.Another ctag was used to complete procedure.The procedure was prolonged for about 30mins to remove the ctag.The patient had minor ischemia bowel syndrome causing by trouble shooting of ctag within three days after procedure.He tolerated the procedure and has recovered now.

Manufacturer Narrative

Update b1, b2, b5, g3.Imaging evaluation: one jpeg image received for evaluation.No name, date, or demographics on the radiographic image.Image provided appears to show a partially deployed and partially constrained device.Engineering evaluation: the proximal end of the device was still constrained, and the deployment line associated with the leading end was broken as described in the event description.The slip knots that constrain the proximal end of the device had not released and showed no signs of tensile strain, damage, or incorrect fiber routing.The core and outer wrap of the fiber appeared to have experienced tensile forces and are not indicative of a clean cut.A split to the inner core is present which may have resulted in a weakened fiber, but this relationship and the cause of the split could not be confirmed.The reason for deployment not completing on the proximal end of the device is likely due to break of the leading end deployment line before the slip knots could release.The cause of the deployment line breaking could not be confirmed with the currently available information.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14570840
• MDR Text Key: 293365536
• Report Number: 2017233-2022-02978
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618033
• UDI-Public: 00733132618033
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TGU313110
• Device Catalogue Number: TGU313110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male