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

Model Number VBHR131002A

Device Problem Migration (4003)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/09/2023

Event Type  Injury  

Event Description

The following information was reported to gore by the field sales associate: on an unknown date, two 13mm x 10cm gore® viabahn® endoprosthesis (vsx device) were reportedly implanted in the iliac vein for treatment of arteriovenous malformation (avm).It was reported two wallstent¿ endoprosthesis - boston scientific devices (18mm) were also implanted to treat avm.It was also reported there was not a gore field sales associate present during the procedure to provide clinical support.It was reported, on (b)(6) 2023, the patient was admitted to the emergency room for unknown reason.It was reported, on an unknown date, it was identified that all four devices had migrated from the iliac vein into the heart.The physicians reported suspected cause of the devices migrating were due to incorrect device sizing for the anatomical location during the initial procedure.It was reported, on (b)(6) 2023, the patient was admitted to the hospital for an open procedure to explant the four device that migrated into the heart.All four device were reported to have been successfully explanted.The patient tolerated the procedure.

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.The device was discarded at the facility.Consequently, a direct product analysis was not possible.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Migration is listed as a possible adverse event that may occur with the use of any gore® viabahn® endoprosthesis with heparin bioactive surface or in any endovascular procedure in the device ifu.Appropriate sizing instructions are not provided for the off-label application of treatment of avm within the iliac vein.However, the following warnings regarding sizing in general are listed in the ifu.The ifu states ¿special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.Failure to follow the appropriate device sizing recommendations or failure to ensure proper device placement, including overlap conditions, prior to deployment can result in ischemic conditions, vessel damage/rupture, and related serious harms, potentially necessitating surgical intervention.¿ ¿physicians should take note that the safety and effectiveness of this device has not been established in applications other than the stated indications for use.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.Actions of a healthcare professional/device user, if inconsistent and/or non-conforming to a manufacturer¿s intended uses, recommendations, instructions for use (ifu), or recognized best practices related to device-device compatibility, may result in or contribute to an adverse event.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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16312307
• MDR Text Key: 308951374
• Report Number: 2017233-2023-03697
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132646142
• UDI-Public: 00733132646142
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VBHR131002A
• Device Catalogue Number: VBHR131002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Date Device Manufactured: 07/31/2022
• 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; Other; Required Intervention