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

Catalog Number VBH131002W

Device Problem Separation Failure (2547)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface warnings section state: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with heparin bioactive surface in applications where the device is deployed within stents or stent grafts other than the gore® viabahn® endoprosthesis with heparin bioactive surface or the gore® viabahn® endoprosthesis.Other devices may interfere with the deployment of the gore® viabahn® endoprosthesis with heparin bioactive surface resulting in deployment failure or other device malfunction.

Event Description

It was reported to gore that a 13mm x 10cm gore® viabahn® endoprosthesis was to be implanted for treatment of an iliac artery occlusion using a sandwich technique.The device was advanced to the target lesion.Deployment was started but the deployment line broke before device was fully expanded.After about half an hour, the endoprosthesis was completely expanded.A portion of the deployment line was left inside the patient's body.The rest of the deployment line was retracted from the patient's body by using a cutter of the surgical stapler.The endoprosthesis remains implanted.The patient tolerated the procedure.

• 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: vickie lang ; 9285263030
• MDR Report Key: 8195219
• MDR Text Key: 131378236
• Report Number: 2017233-2018-00796
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Catalogue Number: VBH131002W
• Device Lot Number: 18565413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 07/16/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 78 YR