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

Catalog Number PAH110502B

Device Problems Separation Failure (2547); Migration (4003)

Patient Problem Fistula (1862)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: terumo destination 90 dilator, amplatz superstiff 260 wire.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 gore® viabahn® endoprosthesis with propaten bioactive surface was being used in a procedure.During device deployment, the deployment line would not release from the delivery catheter.The physician then cut off the deployment knob and fed the deployment line through the terumo destination dilator.He then inserted the dilator over the line into the patient up to the deployed gore® viabahn® endoprosthesis with propaten bioactive surface.With this technique the line was able to be dislodged from the deployed device.A second gore® viabahn® endoprosthesis with propaten bioactive surface was advanced and deployed to complete this treatment, since the first one had displaced itself slightly, due to the manipulation.The patient outcome was fine.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8152272
• MDR Text Key: 130616226
• Report Number: 2017233-2018-00756
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2019
• Device Catalogue Number: PAH110502B
• Device Lot Number: 15254430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR