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

Catalog Number TGU282815

Device Problems Premature Activation (1484); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent treatment of a thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis.It was reported during the procedure due to tight access vessels the device was advanced without a sheath.The device reportedly met resistance while being advanced.It was reportedly suspected by the physician the device was being caught on a previous placed dacron graft in the abdominal aorta.The device was reportedly withdrawn without being implanted due to the resistance that was met.During withdrawal of the delivery catheter, notable resistance was reportedly met, the leading olive became separated from the delivery catheter, and the device pre-deployed.It was reported the device was explanted.A second conformable gore® tag® thoracic endoprosthesis was inserted into the patient.However, the device also met resistance at the level of the previously placed dacron graft.The device was withdrawn due to the resistance being met.It was reported the device was withdrawn with no issues.The device was set aside and discarded.A conduit was used to implant another conformable gore® tag® thoracic endoprosthesis device and the procedure was completed.The aneurysm was repaired and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that these lots met all pre-release specifications.Additional devices involved: tgu313110/11397305.

Event Description

On (b)(6) 2015, the patient underwent treatment of a thoracic aortic aneurysm with a conformable gore tag thoracic endoprosthesis.It was reported during the procedure due to tight access vessels the device was advanced without a sheath.The device reportedly met resistance while being advanced.It was reportedly suspected by the physician the device was being caught on a previous placed dacron graft in the abdominal aorta.The device was reportedly withdrawn without being implanted due to the resistance that was met.During withdrawal of the delivery catheter, notable resistance was reportedly met, the leading olive became separated from the delivery catheter, and the device unintentionally pre-deployed in the distal aorta into right common iliac.It was reported a conversion from the abdominal aorta into right common iliac was performed to explant the leading olive and the device from the patient.The right hypogastric artery was reportedly covered due to the unintentional deployment and was repaired during the conversion.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Corrected date of event.Corrected date gore aware.

• 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: marcos ayala ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4460770
• MDR Text Key: 5320574
• Report Number: 2017233-2015-00035
• 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,Followup,Followup
• Report Date: 04/16/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: TGU282815
• Device Lot Number: 13195216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2015; 03/18/2015; 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 64