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

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.The author was contacted to ask for more details like event date, serial no., implant date as well as patient data and possible root cause for patient 4.Date of event was determined as date when literature article was accepted, here (b)(6) 2021.As patient age (b)(6) was determined and as gender male as mentioned in the article (patient 4).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: recanalization of chronic noncirrhotic, nonmalignant splanchnic thrombosesis feasible: a transsplenic assisted patient-tailored approach published by adrian cobe on july 20, 2021 in the journal of vascular and interventional radiology, pages 1-9.The purpose of this study was to evaluate the feasibility of recanalization of chronic noncirrhotic, nonmalignant splanchnic thromboses with a transsplenic assisted patient-tailored approach with or without transjugular intrahepatic portosystemic shunt (tips) creation.In this retrospective study, 10 patients (median age, 48.4 years) underwent revascularization between november 2016 and august 2020.Portal cavernoma was present in all patients, with complete splenic vein thrombosis in 70%.The technical success rate was 80%.Additional tips creation was performed in 5 (50%) patients.The following adverse events and/or complications were reported: in-hospital complications were encountered in patient 4 with early complete tips (gore¿ viabahn¿ endoprosthesis 8 x 100) thrombosis at day 2 after intervention.Recanalization was successfully performed using thrombolysis, mechanical thrombus aspiration and stent-graft relining.Additional reintervention after 15.5 months for proximal stenosis of the tips and was treated with pta alone.

Manufacturer Narrative

Requests were emailed to the author to provide additional information like patient information, serial number, date of procedure, onset date of occlusion, date of reintervention, imaging series, etc.The requests remained unanswered.The serial number remains unknown, therefore a review of the manufacturing records could not be performed.The device remains implanted in the patient, therefore device evaluations could not be performed.With no additional information provided, gore is unable to perform further investigations of this complaint.As no further information was received from the author, 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: 12315131
• MDR Text Key: 266378663
• Report Number: 2017233-2021-02241
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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
• Date Manufacturer Received: 01/05/2022
• 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: 48 YR
• Patient Sex: Male