MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBJR062502A
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records is pending.The device was not returned.Consequently, a direct product analysis was not possible.
Event or Problem Description
The following was reported to gore by the implanting surgeon: the patient presented with stenosis in the sfa.A gore® viabahn® endoprosthesis was implanted (b)(6) 2018.The patient reported pain (b)(6) 2018 in the area of the implant.Computed tomography angiography (cta) on (b)(6) 2018 revealed the device was performing as expected.Another cta taken (b)(6) 2018 revealed fluid around the gore® viabahn® endoprosthesis.The device was explanted (b)(6) 2018.The doctor reported to gore the fluid around the device was cx positive from perivascular fluid staphylococcus lugdunensis (coagulase-negative, gram-positive bacterium that can be isolated as a component of normal skin flora in humans).
Additional Manufacturer Narrative
Review of the manufacturing records indicated the lots met pre-release specifications.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.
Additional Manufacturer Narrative
Additional manufacturer narrative: refer to medwatch report #2017233-2018-00798 for other gore® viabahn® endoprosthesis involved with this event.
Event or Problem Description
Additional information received indicates that two gore® viabahn® endoprosthesis were implanted (b)(6)2018 and explanted ((b)(6)2018) due to the reported infection.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8231500
• Report Number: 2017233-2019-00010
• Device Sequence Number: 263091
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 18752470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 01/18/2019; 02/07/2019; 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR