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

Catalog Number VBC100502

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Date 09/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient presented with an a-v fistula in the left upper arm.Two gore viabahn® endoprostheses were implanted in this procedure.On (b)(6) 2014, the gore viabahn® endoprostheses had stenosed.A catheter was placed.

Manufacturer Narrative

Concomitant products: two gore viabahn® endoprostheses were implanted.See mfr report #2017233-2014-00516.Review of device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation state the returned deployment line and catheter were found to be unremarkable; the device remains implanted.

Manufacturer Narrative

Gore became aware of the stenosis and subsequent intervention on (b)(6) 2014.Date of event is (b)(6) 2014.

• 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: 4150988
• MDR Text Key: 4931795
• Report Number: 2017233-2014-00515
• 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: 11/21/2014

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: 11/30/2016
• Device Catalogue Number: VBC100502
• Device Lot Number: 12147343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2014
• 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
• Treatment: 11FR BOSTON SCI SHEATH, 035 BENTSON WIRE,
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 59