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

Catalog Number TGM262610E

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The following investigation is planned: product history review, and engineering evaluation of the delivery system.The device is in transit to the manufacturer.Engineering evaluation will be performed once the device is available.

Event Description

On (b)(6) 2022, a gore® tag® conformable thoracic stent graft with active control system (tgm262610e) was implanted in a patient with a rupture of the isthmus.The initial deployment was successful.No resistance was experienced when retracting the catheter, however, the olive separated from the catheter and remained on the guide wire.The olive came out from the patient with the guide wire and there were no issues for the patient.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.The delivery system of the device was returned to w.L.Gore for investigation.Engineering evaluation of the device showed the following: both the vestamid and braided shaft were broken near the trailing transition.The catheter length from the trailing transition to skive was elongated, and both ends of the breakage exhibited twisted deformation of the vestamid outer catheter material.The breakage of the leading end of the catheter was likely due to over torquing of the deliver catheter as described in the event description.The report of olive separation of the catheter was not confirmed.However, the leading end of the catheter was separated proximal to the trailing transition.The reports of device migration after deployment and difficulty ensuring proper positioning of the proximal marker within the leading olive could not be confirmed.The migration event does not meets the specification of a reportable event, as there are no reintervention, coverage of a visceral vessel or aneurysmal/aortic growth.Per the gore® tag® conformable thoracic stent graft instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: stent fracture; migration; and improper placement.Updated b5: describe event or problem.Corrected h6: added type of investigation code b13 - communication/interviews.Updated investigation findings code to c19 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to d1102, d15, and d12.Code 11 is no longer applicable.

Event Description

On may 9, 2022, a gore® tag® conformable thoracic stent graft with active control system (tgm262610e) was implanted in a patient with a rupture of the isthmus.The physician experienced some difficulties placing the device, turning it multiple times to achieve the desired marker position (while the device still remained in the introducer sheath).The initial deployment was successful, whoever, as the device was fully deployed, the device moved 2-3 cm distally.No resistance was experienced when retracting the catheter, however, the olive separated from the catheter and remained on the guide wire.To compensate the distal movement, a second tgm262610e was placed without any issues on the proximal zone.The patient is doing well.

Manufacturer Narrative

Per the gore® tag® conformable thoracic stent graft instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: stent fracture; migration; and improper placement.In addition, the ifu warns: -do not rotate the delivery catheter while the stent graft is inside the introducer sheath.Catheter breakage or inadvertent deployment may occur.-do not rotate the delivery catheter with device outside of the introducer sheath more than 180° in either direction.Catheter breakage or inadvertent deployment may occur.Corrected h6: added health effect - impact code f2301 - additional device required.Added medical device problem code a2303 - improper or incorrect procedure or method, and a150202 - malposition of device.Removed investigation conclusions code d15 (code is no longer applicable).

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14451451
• MDR Text Key: 292501459
• Report Number: 2017233-2022-02941
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/10/2022

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 Catalogue Number: TGM262610E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 09/30/2022; 11/05/2022
• Supplement Dates FDA Received: 10/28/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2021
• 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): Other
• Patient Age: 38 YR
• Patient Sex: Male