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

Catalog Number VBJR062502A

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Stenosis (2263)

Event Date 12/09/2018

Event Type  Injury  

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 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).

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.

Manufacturer Narrative

Additional manufacturer narrative: refer to medwatch report #2017233-2018-00798 for other gore® viabahn® endoprosthesis involved with this event.

Event 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
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8231500
• MDR Text Key: 132526758
• Report Number: 2017233-2019-00010
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623976
• UDI-Public: 00733132623976
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR