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

Catalog Number TGU343415J

Device Problems Break (1069); Leak/Splash (1354); Difficult To Position (1467); Premature Activation (1484); Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the patient underwent an emergent endovascular procedure using conformable gore® tag® thoracic endoprosthesis to repair rupture of a penetrating atherosclerotic ulcer (pau).The patient's aorta and bilateral iliac arteries were extremely calcified.A gore® dryseal sheath with hydrophilic coating (dsl2228j/13275256) was inserted from right side and was advanced only up to the right common iliac artery due to extreme calcification.A conformable gore® tag® thoracic endoprosthesis (tgu343415j/13663276) was advanced outside the sheath, and the device could not reach the intended position.The physician elected to remove the device; however the device was stuck at the leading end of the sheath and could not pull back within the sheath.The physician removed the device and the sheath together, and during the removal, the deployment line broke and the device partially deployed.The device was not implanted and was removed from the patient with no reported issues.Another conformable gore® tag® thoracic endoprosthesis was implanted using a 20fr.Gore® dryseal sheath with hydrophilic coating.An angiography revealed a proximal type i endoleak, and touch up ballooning was performed.The final angiography showed that the endoleak slightly persisted, and the physician elected to monitor the patient.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4708679
• MDR Text Key: 5718860
• Report Number: 2017233-2015-00245
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2015

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: 02/24/2018
• Device Catalogue Number: TGU343415J
• Device Lot Number: 13663276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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 Age: 82 YR