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

Catalog Number PAC050502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The concomitant medical products were two gore® viabahn® endoprosthesis.The therapy date was (b)(6) 2016.Lot/ serial: 13203829 = (b)(4).Lot/ serial: 12944855 = (b)(4).

Event Description

A non-gore sponsored clinical trial/study is being done at (b)(6) hospital to investigate the efficiency, mechanism of action and safety of creating an av fistula for the treatment of critical limb ischemia, first-in man clinical investigation study.After enrollment into the clinical study on (b)(6) 2016, the patient was implanted with three gore® viabahn® endoprostheses on (b)(6) 2016.The implant procedure was performed in the lower right limb in the posterior tibial vein.On (b)(6) 2016, the patient was confirmed with the poor healing-medial malleolus wound.The viabahn® devices were exposed, with surrounding purulent discharge.The patient then underwent a right lower limb wound debridement and the three infected viabahn® devices were explanted on (b)(6) 2016.As reported by the user facility, the poor healing and the infection were not considered to be caused by the viabahn® devices but rather by the initial surgery to cut down for venous access that was done prior to implant procedure.The patient recovered well and was discharged on (b)(6) 2016.Patient is reported to be doing well at this time.

• 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 86005
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6378825
• MDR Text Key: 69105377
• Report Number: 2017233-2017-00102
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2017
• Device Catalogue Number: PAC050502
• Device Lot Number: 13217550
• 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: 06/25/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR