MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJR061502A

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

During an abdominal aortic aneurysm (aaa) procedure, a 6mm x 15cm gore viabahn® endoprosthesis was used as a snorkel device in the left renal artery.The device was advanced through a 6fr ansell introducer sheath and positioned into the left renal artery via axillary artery access.During device deployment, approximately 30% of the gore viabahn® endoprosthesis deployed when the deployment line became difficult to pull.The delivery catheter was manipulated in an attempt to untangle the deployment line without success.During the delivery catheter manipulation, the device moved proximal to the intended deployment site.A low pressure balloon was then advanced into the gore viabahn® endoprosthesis and used the reposition the gore viabahn® endoprosthesis to the intended target site.At the closed of the procedure, it was believed that some of the deployment line may have caught on part of the aaa aortic cuff and remained inside the patient.

Event Description

During an abdominal aortic aneurysm (aaa) procedure, a 6mm x 15cm gore viabahn® endoprosthesis was used as a snorkel device in the left renal artery.The device was advanced through a 6fr ansell introducer sheath and positioned into the left renal artery via axillary artery access.During device deployment, approximately 30% of the gore viabahn® endoprosthesis deployed when the deployment line became difficult to pull.The delivery catheter was manipulated in an attempt to untangle the deployment line without success.During the delivery catheter manipulation, the device moved proximal to the intended deployment site.A low pressure balloon was then advanced into the gore viabahn® endoprosthesis and used the reposition the gore viabahn® endoprosthesis to the intended target site and to fully deploy the device.At the closed of the procedure, the device was fully deployed; however, it was believed that some of the deployment line may have caught on part of the aaa aortic cuff and remained inside the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The device was fully deployed in the event description.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4480156
• MDR Text Key: 5331469
• Report Number: 2017233-2015-00064
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2017
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 13129459
• 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: 10/08/2014
• 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 Age: 77 YR