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

Catalog Number JHH130502J

Device Problem Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, this patient underwent an endovascular procedure to repair bilateral iliac artery aneurysms using gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis with gore® viabahn® endoprosthesis with heparin bioactive surface.A guidewire was advanced from the right side to the left internal iliac artery, and a 12fr sheath was advanced.The first 13x5 gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the artery with no issues.During deployment of the second 13x5 endoprosthesis in the same artery, the physician began to pull the deployment line but stopped.When the physician started to pull the deployment line again, the hub side of the endoprosthesis was not able to be deployed.The physician manipulated/moved the delivery catheter, and the endoprosthesis was able to be fully deployed.However, the deployment line was not able to be withdrawn.The deployment line was cut near the deployment knob, and the delivery catheter was withdrawn from the patient.The 12 fr sheath was exchanged to a 20 fr sheath, and the deployment line was positioned inside the sheath.Endoscopic scissors were advanced to the sheath, and the deployment line was cut as short as possible by the scissors.After that, the procedure was continued as planned.A portion of the deployment line remained inside the patient was pinned between the vessel wall and gore® excluder® iliac branch endoprosthesis deployed later in the procedure.The procedure was concluded, and 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: douglas rhodes ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8137617
• MDR Text Key: 129481154
• Report Number: 2017233-2018-00744
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: JHH130502J
• Device Lot Number: 18497382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 07/07/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR