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

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/07/2023

Event Type  Injury  

Event Description

The following literature was reviewed.¿treatment result of viabahn stent graft for complications after gastroenterological surgery¿ takayuki miura, et al.Journal of abdominal emergency medicine, 2023: 43(2) p.357 the treatment result of 8 patients who were treated of postoperative complications using the gore® viabahn® endoprosthesis with heparin bioactive surface in this hospital was reviewed.The patient median age was 68 years old.Three patients were transferred from another hospital to arrest hemorrhage.Four patients had undergone pd, two had hpd, one had bile duct resection and one had total gastrectomy.The viabahn devices were implanted to treat the bleeding with pancreatic fistula in six patients, a stenosis after reconstruction of artery in one case and an arcuate ligament syndrome in one case.On the next day of ivr, the hepatic enzyme was risen in two patients, but it was reduced in three patients and it was normal in another three patients.The median length of hospitalization was 15 (6-76) days.One patient (hpd) had performed a laparotomy drainage but this patient developed a sepsis and died during hospitalization.There was no occlusion of the stent graft during hospitalization.The occlusion of the stent graft was observed in two patients during follow-up period (the median of the patent period was 17.8 months).This treatment can arrest hemorrhage with maintaining a peripheral blood flow and it is effective to treat a postoperative complications, like a bleeding from a pseudoaneurysm or a stenosis of an artery.On other hand, it is important to treat the focus of infection simultaneously because a viabahn might be implanted in a patients who developed an infection.

Manufacturer Narrative

C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: code ¿other¿ was selected as no device information (serial or lot number) is available and no device was returned.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17255108
• MDR Text Key: 318443537
• Report Number: 2017233-2023-04081
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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