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

Catalog Number VBJ071002

Device Problems Break (1069); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/23/2015

Event Type  Injury  

Event Description

In a aaa procedure, multiple medical devices were used.Gore® viabahn® endoprostheses were placed in the each renal artery.The delivery sheaths were removed and the gore® viabahn® endoprosthesis in the right renal artery was deployed with no issues.However, the deployment line became stuck and broke during deployment of the device in the left renal artery.The gore® viabahn® endoprosthesis remained constrained at the distal tip.Due to difficulty in removing the delivery catheter of the gore viabahn endoprosthesis, wire access to the left renal artery was lost and attempts to recannulate were unsuccessful.Angiography confirmed patency into the right renal artery.The left renal artery was excluded from flow due to the partially constrained viabahn device.The physician chose to discontinue the procedure.Patient is currently in good health with no significant elevation of serum creatinine.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.

Manufacturer Narrative

Patient medical history was received from user facility.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4775757
• MDR Text Key: 5804148
• Report Number: 2017233-2015-00293
• 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: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2017
• Device Catalogue Number: VBJ071002
• Device Lot Number: 13471328
• 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: 01/22/2015
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 155