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

Catalog Number PAH130502B

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore viabahn® endoprosthesis instructions for use (ifu), once deployment is started, repositioning the endoprosthesis should not be attempted.

Event Description

On (b)(6) 2017 a patient was undergoing treatment of an arterio-venous access outflow stenosis, cephalic vein, with a 13mm x 5mm gore viabahn endoprosthesis with heparin bioactive surface.There was reportedly no calcium present in the treatment area.When the device was being deployed, the delivery catheter was moved forward by the physician and the deployment line became stuck.The device was partially deployed at this point.Then the delivery catheter was attempted to be pulled back.Another attempt to deploy the remainder of the device was made, but the deployment line broke.The stent did fully expand, therefore the physician made a small incision at the area where the stent deployed and cut the deployment line, leaving some line at the proximal edge of the stent.The patient was stable following 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6684307
• MDR Text Key: 78986965
• Report Number: 2017233-2017-00329
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: PAH130502B
• Device Lot Number: 15385192
• 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: 06/01/2016
• 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): Hospitalization; Other; Required Intervention