MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Catalog Number VBJR061002A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Additional 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.All information has been placed on file for use in tracking and trending.Lot number: (b)(4).The doctor reported the deployment line and catheter were pulled simultaneously, bringing the deploying gore® viabahn® endoprosthesis partially into the sheath.The instructions for use, section g.'deployment of the gore® viabahn® endoprosthesis' instruct: stabilize the delivery catheter at the hemostasis valve of the introducer sheath.It is also important to stabilize the delivery catheter and introducer sheath relative to the patient.This will minimize catheter movement during deployment and ensure accurate endoprosthesis positioning.

Event Description

The complainant called gore and reported the following: patient was being treated for subclavian artery stenosis.Upon removal of 6fr sheath, extra luminal contrast was noted at branch of epigastric artery off external iliac on patient¿s right side.A gore® viabahn® endoprosthesis was advanced through 6fr bsc 11cm sheath over a.014in wire on patient's right side (ipsilateral approach).The doctor asked the tech to deploy the gore® viabahn® endoprosthesis.The doctor reported the deployment line and catheter were pulled simultaneously, bringing the deploying gore® viabahn® endoprosthesis partially into the sheath.When this was noted on fluoro, attempt was made to withdraw sheath distally over the partially deployed gore® viabahn® endoprosthesis.The gore® viabahn® endoprosthesis became "stuck".The sheath could not be removed over the catheter.Continued pulling of gore® viabahn® endoprosthesis occurred and the catheter was eventually removed deploying the gore® viabahn® endoprosthesis partially in the patient and partially out side the patient.The patient was taken to the operating room for removal of gore® viabahn® endoprosthesis and patching of the external iliac artery.The patient is reportedly fine.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 6498186
• MDR Text Key: 72948100
• Report Number: 2017233-2017-00204
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013648
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2019
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 15219731
• 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: 04/22/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR