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

Catalog Number VBJ081002

Device Problem Sticking (1597)

Patient Problem Stenosis (2263)

Event Date 04/28/2015

Event Type  Injury  

Event Description

A gore® viabahn® endoprosthesis was used to repair an in-stent restenosis of the left brachiocephalic arteriovenous fistula.The device was advanced through a 7fr introducer sheath.During deployment, part of the device was caught within the sheath and part of the device was outside the sheath extending into the targeted stenotic lesion.Efforts to remove the sheath and the gore® viabahn® endoprosthesis were unsuccessful.The patient was taken to the operating room for the removal of the sheath and stent graft.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Based on the event description, deployment may have be initiated in a position where a portion of the device was still inside the introducer sheath.As stated in the product¿s instruction for use, ¿once the optimal position is verified fluoroscopically, the endoprosthesis is ready to be deployed.¿.

Manufacturer Narrative

(b)(6).

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4809003
• MDR Text Key: 5893205
• Report Number: 2017233-2015-00325
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: VBJ081002
• Device Lot Number: 12017746
• 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: 12/06/2013
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 84