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

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.

Event Description

The following literature was reviewed." abdominal artery injury treatment with viabahn" tomoki wada md, et al.Journal of abdominal emergency medicine, 2022: 42(2) p237.There were 7 patients who underwent endovascular treatment of an abdominal artery injury using gore® viabahn® endoprosthesis with heparin bioactive surface from june 2018 to september 2021.Regarding the injured vessels, 5 patients were the common hepatic artery or beyond the hepatic artery proper, 1 patient was the splenic artery, and 1 patient was the renal artery.Except for the renal artery case, 6 patients were treated after pancreatic surgery.Guiding sheaths with diameters ranging from 6 fr to 8 fr were used.As a rule, the diameter of the injured vessel was measured using contrast-enhanced ct images at the time of vessel injury and when the vessel was undamaged, and the diameter of the viabahn to be used was determined based on the larger value.No endoleak was observed immediately after surgery.Of the six post-pancreatic surgery cases, the viabahn device was occluded within one month after implantation in three cases and partial hepatic infarction occurred in two cases.None of the patients developed liver failure or re-bleeding.

Manufacturer Narrative

Device serial number remains unknown and device is not accessible for testing.Information was obtained from the following article: the following literature was reviewed." abdominal artery injury treatment with viabahn" tomoki wada md, et al.Journal of abdominal emergency medicine, 2022: 42(2) p237.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15180262
• MDR Text Key: 297412620
• Report Number: 2017233-2022-03193
• 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,Followup
• Report Date: 08/17/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other