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

Catalog Number JHH130502J

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.

Event Description

On (b)(6) 2019, this patient underwent an endovascular repair for a brachiocephalic artery aneurysm using a gore® viabahn® endoprosthesis with heparin bioactive surface.Reportedly, the patient anatomy was slightly tortuous.Access was obtained from the axillary artery with cut down.After a sheath was inserted, the first endoprosthesis was implanted with no issue.The second endoprosthesis was also reportedly completely expanded.It was reported, however, the deployment line seemed to be stuck in the edge of the endoprosthesis and was unable to remove the line from the patient.It was reported the physician advanced the sheath near the edge of the second endoprosthesis in an attempt to resolve the issue, but it was unsuccessful.The deployment knob was cut away from the line, and the catheter was withdrawn from the patient.After that, the physician advanced a sheath again over the deployment line and pushed the edge of the endoprosthesis by the tip of the sheath.However, the issue was not resolved.The procedure was completed with the deployment line remaining inside the patient.

Manufacturer Narrative

Engineering evaluation states: based on the available reported information with no device returned, the following observations were made: engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9141373
• MDR Text Key: 160780851
• Report Number: 2017233-2019-00967
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Catalogue Number: JHH130502J
• Device Lot Number: 20623514
• 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