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

Catalog Number JHH110502J

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The device remains implanted.Therefore, direct product analysis was not possible.Instructions for use warnings section states, 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 propaten bioactive surface in applications where the device is deployed within stents or stent grafts other than the gore® viabahn® endoprosthesis.Other devices may interfere with the deployment of the gore® viabahn® endoprosthesis with propaten bioactive surface resulting in deployment failure or other device malfunction.

Event Description

The following was reported to gore: on (b)(6) 2017, a patient underwent endovascular procedure to repair an abdominal aortic aneurysm using non-gore stent graft (afx).After the stent graft was deployed, decision was made to implant a gore® viabahn® endoprosthesis in the external iliac artery.When the deployment of the viabahn endoprosthesis was started, strong resistance was noted.It was suspected that the deployment line was caught on an internal stent of the afx stent graft.The treatment site was located in a tortuous portion of the external iliac artery, possibly contributing to the deployment line getting stuck.The deployment line was pulled with some force while manipulating the delivery catheter to release the line.This resulted in full deployment of the endoprosthesis.The delivery catheter was then able to be withdrawn.As reported, the endoprosthesis was unintentionally shortened during manipulation of delivery catheter to release the deployment line.The deployment line was intentionally cut using forceps.A gore® excluder® aaa endoprosthesis was deployed to affix the remaining portion of the deployment line against the patient's vessel.The viabahn device remains implanted.The procedure was completed with no further issues.As reported, the patient did not experience any adverse consequences.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7177046
• MDR Text Key: 96958319
• Report Number: 2017233-2018-00012
• 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: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2019
• Device Catalogue Number: JHH110502J
• Device Lot Number: 15979402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• 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: 85 YR