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

Catalog Number PAJ050502

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 01/03/2014

Event Type  Injury  

Event Description

It was reported that on an unknown date the patient was implanted with a non-gore device to treat an abdominal aortic aneurysm.The follow-up revealed a migration of the device and contrast in the aneurismal sac.On an unknown date a gore tag thoracic endoprosthesis and three gore viabahn endoprostheses were used to treat the aneurysm and save the renal arteries.It was reported to gore that on (b)(6) 2014, there was no blood flow to the kidneys.It was stated that a gore hybrid vascular graft was implanted for an iliac-femoral bypass.The patient tolerated the procedure.

Event Description

It was reported that on an unknown date the patient was implanted with a non-gore device to treat an abdominal aortic aneurysm.The follow-up revealed a migration of the device and contrast in the aneurismal sac.On (b)(6) 2014, a conformable gore tag thoracic endoprosthesis and three gore viabahn endoprostheses were used to treat an abdominal aortic aneurysm and perfuse the renal arteries.It was reported to gore that during the procedure it was noted that there was no blood flow to the renal arteries.It is unknown as to what caused the occlusion of the renal arteries.A gore hybrid vascular graft was implanted to re-perfuse one of the kidneys.The patient tolerated the procedure.On an unknown date the patient expired due to respiratory failure.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3718855
• MDR Text Key: 4252533
• Report Number: 2017233-2014-00170
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: PAJ050502
• Device Lot Number: 11446267
• 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: 06/06/2013
• 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
• Treatment: TAG LOT 11126160, VIABAHN LOT 9822335, 11544179
• Patient Outcome(s): Required Intervention