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

Catalog Number JHJR052502J

Device Problems Difficult or Delayed Activation (2577); Difficult or Delayed Separation (4044)

Patient Problem Occlusion (1984)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Event Description

On (b)(6) 2019 the patient underwent an endovascular procedure using a gore® viabahn® endoprosthesis to repair occlusion of the right superficial femoral artery.The gore® viabahn® endoprosthesis was advanced to the intended position with no reported issues.Upon initiating deployment, the deployment line broke and became separated before the device fully expanded.The physician cut the delivery catheter at the hub and found the broken deployment line within the catheter lumen.The broken line was pulled to fully open the device; however the device remained partially constrained.The physician finally removed the catheter from the patient, and this fully opened the device with no reported issues.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: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8875667
• MDR Text Key: 154304714
• Report Number: 2017233-2019-00606
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 20105145
• 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: 11/25/2018
• 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