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

Catalog Number TGU454520

Device Problems Bent (1059); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, a patient was being treated for a thoracic aortic aneurysm with several gore® tag® thoracic endoprostheses.It was reported the patient had very tortuous anatomy and prior to inserting the sheath, several dilators were used to make sure the sheath would advance.The sheath was advanced over a lundquist stiff wire.It was noted that upon advancing the sheath on fluro that the sheath was slightly bent (not kinked).The tgu454520 was advanced and deployed without issue.While the physician was removing the catheter for the tgu454520 the leading olive got stuck halfway down in the sheath.The physician used force to pull the catheter and the leading olive popped off in the sheath.The sheath was removed with the leading olive remaining inside the sheath.A new sheath was used and the remaining devices were implanted without issue.The patient tolerated the procedure.The dsl2428 and the tgu454520 catheter will be returned to gore for evaluation.

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot(s) met all pre-release specifications.The results of the engineering evaluation are as follows: the device evaluation for the conformable gore® tag® thoracic endoprosthesis showed the following: the leading end of the dual lumen separated from the remainder of the catheter body.The condition of the broken leading end of the conformable gore® tag® thoracic endoprosthesis catheter was indicative of necking and breaking of the dual lumen.The findings from the evaluation are consistent with the physician¿s observations.The root cause for the leading end of the dual lumen detaching from the conformable gore® tag® thoracic endoprosthesis catheter was the retraction of the catheter against resistance.The indications for use section of the ifu states, ¿do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.Stop and assess the cause of resistance.Vessel, endoprosthesis, or delivery catheter damage may occur.¿.

• 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 86005
• Manufacturer Contact: natalie putnam ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5547257
• MDR Text Key: 42613436
• Report Number: 2017233-2016-00318
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/19/2016

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: 09/29/2018
• Device Catalogue Number: TGU454520
• Device Lot Number: 14490998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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: 73 YR
• Patient Weight: 75