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

Catalog Number VBHR080502A

Device Problems Optical Decentration (1360); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing endovascular thoracic aorta repair.The access site included the use of a perclose mechanical closure system.However during the closure, the femoral artery became damaged.An attempt to repair the damaged artery was made by advancing a gore® viabahn® endoprosthesis.This device was advanced over a.035¿ lunderquist wire through a 7fr.Terumo sheath.During deployment, when the device was half way expanded, the deployment line broke.An additional gore® viabahn® endoprosthesis was advanced and deployed properly, however the artery had clotted off.A bypass procedure was then performed with success.The patient did well following the bypass procedure.

Event Description

The following information was reported to gore: on (b)(6) 2018 a patient was undergoing a transcatheter aortic valve replacement.The access site included the use of a perclose mechanical closure system.However during the closure, the femoral artery became damaged.An attempt to repair the damaged artery was made by advancing a gore® viabahn® endoprosthesis.This device was advanced over a.035¿ lunderquist wire through a 7fr.Terumo sheath.During deployment, when the device was half way expanded, the deployment line broke.An additional gore® viabahn® endoprosthesis was advanced and deployed properly, however the artery had clotted off.A bypass procedure was then performed with success.The patient did well following the bypass procedure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7394538
• MDR Text Key: 104248925
• Report Number: 2017233-2018-00203
• 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: 05/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: VBHR080502A
• Device Lot Number: 15667826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2018; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 62