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

Catalog Number TGE212110

Device Problems Difficult to Insert (1316); Unintended Collision (1429)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the patient was implanted with a conformable gore® tag® thoracic endoprosthesis to treat a post coarctation repair aneurysm percutaneous access was performed at the right inguinal area.An 18fr cook sheath was inserted where after the conformable gore® tag® thoracic endoprosthesis(tge212110) was inserted into the patient.A secondary entry was made in the cook sheath by placing a needle into the valve of the sheath.A guidewire pigtail catheter were inserted through this entry.This entry caused a severe blood leakage through the valve of the cook sheath.The physicians decided to exchange the sheath.During removal of the delivery system of the conformable gore® tag® thoracic endoprosthesis (tge212110) the leading olive caught at the valve of the sheath and resistance was felt.By trying to pull the device out of the sheath the leading olive separated from the device delivery system.The disconnected delivery system was removed.After this the sheath together with the olive remaining in the valve were retrieved as well.A second conformable gore® tag® thoracic endoprosthesis (tge212110) was implanted successfully and the patient was doing well following 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: ruth kunzmann ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4670607
• MDR Text Key: 5731530
• Report Number: 2017233-2015-00221
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2017
• Device Catalogue Number: TGE212110
• Device Lot Number: 13439033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR