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

Catalog Number VBH070502

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

The complainant called gore and reported the following: the gore viabahn® endoprosthesis was inserted into a short 8fr sheath in the right groin going up and over into the left iliac artery over a wire.The gore viabahn® endoprosthesis catheter was pulled back to remove the device.When the catheter was fully removed out of the patient it was observed the prosthesis was not on the catheter.The rip cord was free from the catheter and the status of the prosthesis (deployed/not deployed) was not visualized within the left artery.A 7fr catheter was inserted over the gore viabahn® endoprosthesis deployment cord and up and over to the left iliac butting up to the prosthesis.The deployment cord was pulled and the device obtained full deployment.The case was finished with the gore viabahn® endoprosthesis successfully deployed in the left iliac.According to the complainant, flow looked good.

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.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.The instructions for use warn to 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, we recommend to 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.

Manufacturer Narrative

(b)(4).

• 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 86001
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4649477
• MDR Text Key: 5757619
• Report Number: 2017233-2015-00199
• 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,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBH070502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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