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

Catalog Number VBC061502

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.Sterilization process review, the review of the manufacturing and sterilization paperwork verified that this lot met all pre-release specifications.(b)(4).This event involves two devices: device 1 - lot #12864368, mfr report #2017233-2015-00800.Device 2 - lot #11398931, mfr report #2017233-2015-00801.

Event Description

As reported, on (b)(6) 2015, a gore viabahn® endoprosthesis was used to treat a bare-metal stent(bms) in-stent stenosis.The intent was to use the gore viabahn® endoprosthesis to reline the bms.The device was implanted in the subintimal space adjacent to the bms and then re-entered the sfa lumen distal to the bms.At the close of the procedure, there was air space present between the bms and viabahn device.A week after implant, the patient presented with signs of infection.Reportedly, the gore viabahn® endoprosthesis became infected and was explanted on (b)(6) 2015.

• 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 ; 9285263030
• MDR Report Key: 5232202
• MDR Text Key: 31455180
• Report Number: 2017233-2015-00801
• 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
• Report Date: 10/26/2015

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: 03/31/2016
• Device Catalogue Number: VBC061502
• Device Lot Number: 11398931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90