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

Catalog Number VBH111002A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Aneurysm (1708)

Event Date 09/17/2019

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient underwent treatment of a common femoral artery aneurysm.Two gore® viabahn® endoprostheses were utilized in the procedure.On an unknown date the two devices became separated, reportedly due to movement within the aneurysm.On (b)(6) 2019 a reintervention took place whereby an additional viabahn was place to bridge the two separated components.The patient did well following the procedure.

Manufacturer Narrative

Two gore® viabahn® endoprostheses were overlapped and implanted during the implant procedure.The second device information is lot #20454035, item #vbh131002a, udi # (b)(4).

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9192615
• MDR Text Key: 162653997
• Report Number: 2017233-2019-01027
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2020
• Device Catalogue Number: VBH111002A
• Device Lot Number: 17796280
• 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: 71 YR