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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

The author was contacted to ask for more details like event dates, serial no's, implant dates as well as patient data and possible root causes.Date of event was determined as date when literature article was accepted, here july 5, 2020.As patient age the mean age 68 years was determined and as gender male as mentioned in the article.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 literature was reviewed: ¿stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial¿ published by marc bosiers in the journal of cardiovascular surgery 2020 october;61(5):617-25.This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device) with a standard pta treatment.A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between june 2010 and february 2012.Among the 83 patients, 3 experienced device-related adverse events within 30 days: occlusions of the study lesion.

Manufacturer Narrative

Requests were emailed to the author to provide additional information like patient information, serial numbers, dates of procedure, onset date of occlusion, date of reintervention, imaging series, etc.The requests remained unanswered.The serial numbers remain unknown, therefore a review of the manufacturing records could not be performed.The devices remain implanted in the patients, therefore device evaluations could not be performed.With no additional information provided, gore is unable to perform further investigations of this complaint.This investigation is considered complete, the cause of the complaint was unable to be determined.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12296334
• MDR Text Key: 265798221
• Report Number: 2017233-2021-02227
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Male