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

Catalog Number PAH101502B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Unspecified Immune System Problem (4435)

Event Date 09/05/2020

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2020, the gore® viabahn® endoprosthesis with heparin bioactive surface was implanted for treatment of popliteal aneurysm.Reportedly after arriving in recovery, patient had no foot pulse.It was reported that a few days post implant the patient was admitted to public hospital emergency room with acute ischemic leg.On (b)(6) 2020, an urgent open procedure bypass was performed.Patient outcome is unknown.

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.Due to no device return, an investigation could not be performed.

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.

Manufacturer Narrative

It was unclear as to which device was involved in adverse event so lot/serial# 20558314 catalog # pah111002b is also included in this mdr.Phr for both devices-a review of the manufacturing records indicated the device met pre-release specifications.Corrected product code and changed health effect clinical code.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13905932
• MDR Text Key: 287932012
• Report Number: 2017233-2022-02823
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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,Followup
• Report Date: 06/14/2022

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: 06/14/2022
• Device Catalogue Number: PAH101502B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 02/25/2022; 02/25/2022
• Supplement Dates FDA Received: 03/28/2022; 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Male