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

Catalog Number JHH130502J

Device Problem Separation Failure (2547)

Patient Problem Aneurysm (1708)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.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

The following was reported to gore: on (b)(6) 2019, the patient underwent endovascular procedure to repair a left external iliac artery aneurysm using gore® viabahn® endoprosthesis with heparin bioactive surface.While deploying the device, resistance was encountered and the stent graft would not fully deploy.The physician continued to pull the deployment line to get the device to fully deploy.The device was moved when the physician attempted to remove the deployment line from the patient.The physician made the decision to cut the deployment line outside the patient¿s body and a 12 mm x 40 mm metal stent (unknown manufacturer) was used to pin the deployment line to the vessel.According to the doctor, approximately 4 to 5 cm of the deployment line remain in the patient, not secured by the metal stent.The procedure was completed without further issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: based on the examination performed and no device and/or images being available for evaluation, no manufacturing anomalies were identified to which the event could be definitively attributed.Based on the engineer evaluation of the information obtained during the investigation, no product design or manufacturing anomalies were detected.

Manufacturer Narrative

Additional manufacturing narrative: g5 - pre-1938.G5 - otc product.Corrected data: b2 - outcomes attributed to adverse event.H6 - method code 2.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8962790
• MDR Text Key: 156602947
• Report Number: 2017233-2019-00791
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: JHH130502J
• Device Lot Number: 18637295
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR