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

Model Number	VBHR071002A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Obstruction/Occlusion (2422)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on an unknown date the patient was implanted to treat the patient for an unknown etiology using a gore® viabahn® endoprosthesis.On an unknown date, the patient tested positive for both a nickel and gold allergy.
Event or Problem Description
The following information was reported to gore: on an unknown date in (b)(6) 2020, the patient underwent treatment for endofibrosis in the patient¿s left external iliac artery using a gore® viabahn® endoprosthesis.On an unknown date, the patient presented with pain reportedly due to dermatitis.On an unknown date, the patient tested positive for both a nickel and gold allergy.On an unknown date, occlusion of the gore® viabahn® endoprosthesis was identified.On (b)(6) 2021, the patient underwent a reintervention whereby the gore® viabahn® endoprosthesis was excised in continuity with the external iliac artery.The patients anatomy was reconstruct with a dacron graft.The physician reportedly decided to explant the device due to the patient¿s dermatitis and related pain as well as the identified occlusion.The patient tolerated the procedure.
Additional Manufacturer Narrative
Suspect product.Component code.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Corrected e1 - initial reporter name and address.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11389186
• Report Number: 2017233-2021-01715
• Device Sequence Number: 1165152
• Product Code: NIP
• UDI-Device Identifier: 00733132622986
• UDI-Public: 00733132622986
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2022

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 Expiration Date: 09/06/2022
• Device Model Number: VBHR071002A
• Device Catalogue Number: VBHR071002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 01/14/2022
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female