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

Catalog Number VBC090502A

Device Problems Difficult or Delayed Positioning (1157); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

During an a-v access procedure in the patient's upper arm, a 9x4 balloon was used to dilate the target lesion.An 11fr introducer sheath was used to advance the gore® viabahn® endoprosthesis over a.035 guidewire.The gore® viabahn® endoprosthesis was placed and deployment was initiated.However, the deployment line became stuck and would not release.The gore® viabahn® endoprosthesis was being pulled back into the sheath when the distal tip of gore® viabahn® endoprosthesis deployed.The introducer sheath was removed with the device.Another gore® viabahn® endoprosthesis was used to complete the procedure.The patient did not experience any adverse consequences.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.Engineering evaluation state the deployment hub and line were not returned.Based on device examination performed, no manufacturing anomalies were identified.Ifu warnings section 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.

Manufacturer Narrative

The completed engineering evaluation state the returned gore® viabahn® endoprosthesis was partially covered proximally by an introducer sheath.The introducer sheath was not evaluated as this is not a gore product.During the evaluation, the introducer sheath was retracted proximally to expose the gore® viabahn® endoprosthesis.The outer layer of the deployment zipper was fully deployed.The inner deployment zipper was deployed approximately 1.5 cm from the end of the gore® viabahn® endoprosthesis near the tip of the catheter.The gore® viabahn® endoprosthesis distal expansion was observed.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4512592
• MDR Text Key: 5533287
• Report Number: 2017233-2015-00090
• 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: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2017
• Device Catalogue Number: VBC090502A
• Device Lot Number: 13197671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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: 11FR SHEATH, .035 GUIDEWIRE, 9X4 BALLOON
• Patient Age: 86 YR