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

Catalog Number JHJR061002J

Device Problem Obstruction of Flow (2423)

Patient Problem Claudication (2550)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® viabahn® endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to thrombosis or occlusion.

Event Description

On (b)(6) 2019, a gore® viabahn® endoprosthesis with heparin bioactive surface was implanted as part of a re-intervention procedure to treat occlusion of a previously placed stent graft.On (b)(6) 2019, the patient reportedly returned to the facility with claudication.Follow-up examination reportedly confirmed an occlusion of the gore® viabahn® device.A femoral-popliteal bypass was scheduled for (b)(6) 2019.Current patient status is unknown.

Manufacturer Narrative

Information regarding re-intervention procedure planned for (b)(6) 2019 and current patient status are unavailable.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8320886
• MDR Text Key: 135539207
• Report Number: 2017233-2019-00072
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: JHJR061002J
• Device Lot Number: 18048201
• 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): Other
• Patient Age: 70 YR