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

Catalog Number VBH091502

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problem Aneurysm (1708)

Event Date 08/13/2014

Event Type  Injury  

Event Description

Patient presented with an aneurysmal segment in the iliac artery.From the contralateral side, a 10fr introducer sheath was used to advance the gore® viabahn® endoprosthesis over the aortic bifurcation.The gore® viabahn® endoprosthesis was placed at the target site.After deployment of the gore® viabahn® endoprosthesis, the deployment line and device catheter were removed.Fluoroscopy revealed the gore® viabahn® endoprosthesis had fully expanded and was patent.Due to the position of the sheath, it was reported the physician had to push the introducer sheath toward the deployed gore® viabahn® endoprosthesis, then forward to remove the sheath from the patient.As the introducer sheath was removed, the gore® viabahn® endoprosthesis was pulled partially out of the patient's body.The physician attempted to pull the exposed gore® viabahn® endoprosthesis further out but it was stuck.The patient was taken to the operating room for surgical repair.

Manufacturer Narrative

Review of device record history confirmed device met pre-release specifications.

• 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: 4072703
• MDR Text Key: 18026780
• Report Number: 2017233-2014-00463
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: VBH091502
• Device Lot Number: 12078449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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 GUIDEWIRE, 10FR INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR