MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH130502A

Device Problems Failure to Advance (2524); Material Distortion (2977)

Patient Problem Tissue Damage (2104)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Device was discarded at user facility.Therefore, direct product analysis was not possible.Warnings section of ifu states: do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

Event Description

Patient presented for an aaa procedure and treatment in the right internal iliac artery.As reported to gore, the patient's vessels were heavily calcified with a very tortuous anatomy.Using.035 amplatz guidewire and a 12fr sheath, the gore® viabahn® endoprosthesis was advanced up and over the bifurcation.The gore® viabahn® endoprosthesis was unable to be advanced to the intended treatment site.Decision was made to remove the gore® viabahn® endoprosthesis and attempts were made to pull the gore® viabahn® endoprosthesis back into introducer sheath.As it was pulled back, the gore® viabahn® endoprosthesis got stuck inside the sheath because the gore® viabahn® endoprosthesis became distorted and compressed.The sheath and gore® viabahn® endoprosthesis had to be removed together.When the introducer sheath was removed, the constrained gore® viabahn® endoprosthesis was left behind in the left common femoral artery.A surgical cut-down was performed to remove the damaged gore® viabahn® endoprosthesis.The patient was reported to be doing well after the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 6062205
• MDR Text Key: 58603092
• Report Number: 2017233-2016-00831
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Catalogue Number: VBH130502A
• Device Lot Number: 13394138
• 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: 11/25/2014
• 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
• Treatment: .035 AMPLATZ GUIDEWIRE, 12FR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75