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

Catalog Number PAJ061502

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

Patient Problem Bacterial Infection (1735)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.A review of the sterilization records confirmed that all lots met all pre-release sterilization specifications.

Event Description

The following information was reported to gore: on (b)(6) 2015, a patient was implanted with a gore® viabahn® endoprosthesis with propaten bioactive surface in the leg.On (b)(6) 2015, the device occluded, and a surgical thrombectomy with ptfe bypass graft procedure was performed.(reported separately).On (b)(6) 2019 the gore® viabahn® endoprosthesis with propaten bioactive surface and surrounding leg tissues were full of pus.The device was explanted and sent to the lab to be cultured.The explanted device was discarded at the facility.

Manufacturer Narrative

The bypass procedure was reported under mfr.Report # 2017233-2019-00710.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8942618
• MDR Text Key: 156396666
• Report Number: 2017233-2019-00753
• 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
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2018
• Device Catalogue Number: PAJ061502
• Device Lot Number: 14377723
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR