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

Device Problem Migration (4003)

Patient Problem Fistula (1862)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

The patient identifier was not provided.Therefore, the gore reference number was used as the patient id.Cause investigation and conclusion the reported information indicates a potential device malfunction, related to device migration after deployment, has occurred.Additional information was requested; however, the following information was not reported to gore: a) unique device identification, b) clinical images enabling direct assessment of product performance, c) product.Detailed information was requested, but no information related to vessel sizing or measurement was provided, and, therefore, a potential cause related to appropriate device size selection could be neither confirmed nor dismissed.The information provided to gore cannot be connected to a specific device, and the cause of the reported potential malfunction could not be established.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined.The reported information indicates a potential reasonably foreseeable misuse may have occurred: reportedly, a larger vsx device likely should have been used instead of the 5 mm vsx device that is the subject of this complaint.In the instructions for use the following is stated: sizing and selection of the gore® viabahn® endoprosthesis with propaten bioactive surface a careful assessment of the vessel is necessary to select the appropriate size(s) of and deployment positions for the gore® viabahn® endoprosthesis with propaten bioactive surface.The endoprosthesis diameter(s) should be approximately 5 ¿ 20 % larger than the healthy vessel diameter immediately proximal and distal to the lesion, to assure adequate anchoring.It is recommended that the device be no more than 20 % oversized as excessive oversizing may adversely impact patency.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

On (b)(6) 2022, the patient underwent an endovascular intervention to treat an arteriovenous fistula that was located 2 cm below the femoral bifurcation.The fistula was treated with a 5 mm x 50 mm gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device).After placement of the viabahn device it was post-dilated with a percutaneous transluminal angioplasty (pta) balloon (6 fr x 40 mm, medtronic).Reportedly, control imaging at the end of the procedure showed satisfactory results.The patient was discharged home at the same day.On (b)(6) 2022, the patient presented at the cardiologist, who discovered that the viabahn device has migrated downwards at mid-thigh by several centimeters.The same day, the patient underwent an endovascular reintervention because of the migration.To recover the migration a pta balloon (6 fr inflation, medtronic) was used to track the migrated viabahn device back to the level of the arteriovenous fistula.Then a second viabahn device (6 mm x 10 cm) was implanted as a proximal extension of the first viabahn device.Reportedly, control imaging at the end of the procedure showed satisfactory results.It was reported that the cause for the migration of the viabahn device most likely was a sizing issue.The physician said that in the present case a 5 mm viabahn device was too small.It was further reported that the intima of the femoral artery was smooth with no calcified plaques present.The physician suspects that this also could have contributed to the migration of the viabahn device.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16043539
• MDR Text Key: 306153057
• Report Number: 2017233-2022-03603
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/23/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male