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

Model Number VBH110502A

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface, and is essentially non-eluting.

Event Description

The following information was reported to gore: on (b)(6) 2020, a patient was undergoing a procedure of unknown type with a gore® viabahn® endoprosthesis.After inserting the device, a separation between the stent and the catheter was noticed.Additionally, the stent was in a position where it would not deploy properly the device and delivery system were removed, and another device was utilized successfully.

Manufacturer Narrative

The information initially reported stated the stent had separated from the delivery catheter.After the device was returned an engineering evaluation was performed.It was identified that the stent moved on the distal shaft but did not separate from the delivery catheter.Therefore this report will be retracted.The gore® viabahn® endoprosthesis instructions for use states, ¿do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath after the endoprosthesis is fully introduced¿.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10880284
• MDR Text Key: 219563745
• Report Number: 2017233-2020-01476
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623259
• UDI-Public: 00733132623259
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P40037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: VBH110502A
• Device Catalogue Number: VBH110502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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