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

Catalog Number VBJR052502A

Device Problems Separation Failure (2547); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2024

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2024, a 5mm x 25cm gore® viabahn® endoprosthesis (vsx device) was intended for use in the distal superficial femoral artery during treatment of in stent re-stenosis of a bare metal stent.Prior to the advancement of the vsx device, the physician performed a thrombectomy with a penumbra system to remove thrombus from the bare metal stent.The physician advanced the vsx device through a 6fr cook introducer sheath over an 0.018" v18 wire and attempted to deploy the device.However, after approximately 10cm of the vsx device was expanded, the deployment line broke.With the vsx device not fully deployed, the physician cut the delivery catheter and located the remainder of the deployment line and tried to continue deploying the device with hemostats.With the inability to continue deployment, the physician decided to perform a cut down to the vessel and cut the deployment catheter as close the stent as he could and leave the undeployed vsx device, deployment catheter and deployment line in the patient.

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.

Manufacturer Narrative

A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Explant/engineering evaluations: a) explant evaluation findings included the following: the specimen was returned to w.L.Gore & associates for investigation.Submitted in formalin was one gore® viabahn® endoprosthesis fragment.The specimen consisted of an excised portion of the femoral artery with adjacent fatty tissue, a portion of a branch artery, and luminally placed vsx fragment within an accordioned/compressed non-gore bare metal stent.Cut ends of a delivery catheter were visible from both extremities.The lumen of the specimen was occluded by the disrupted and accordioned/compressed frame of the bare metal stent.Histopathologic analysis was not performed, as the nature of the complaint was associated with a deployment complication.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.One end of each the non-gore bare metal stent and the vsx fragment were transected.The radiopaque markers and struts of the bare metal stent were found to be intertwined within the vsx stent frame.A portion of the vsx deployment line was found to be intertwined within the bare metal stent.No wear related disruptions were identified.B) engineering evaluation showed the following: the primary reported device failure, related to inability to deploy with partial device expansion, was confirmed following independent evaluations of the returned specimen.An excised viabahn® device was returned entangled within an accordioned/compressed non-gore bare metal stent (bms).There were significant interactions observed between components of the bms and the viabahn® device fragment, including intertwining of the deployment line within bare metal stent struts.The end of the deployment line could not be identified during evaluation as it was obscured by the interactions with the bms.Therefore, it could not be evaluated for a break as reported.Additionally, the viabahn® device was transected at both ends of the endoprosthesis consistent with surgical removal reported by the field.Consequently, a full evaluation of the zipper could not be performed, and release of the zipper constraint beyond the condition in which it was returned was not possible.Observed entanglement of the deployment line with the bms suggests a deployment complication related to events occurring within the procedure (i.E., unintended device interactions).Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: 18531586
• MDR Text Key: 333076026
• Report Number: 2017233-2024-04554
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623938
• UDI-Public: 00733132623938
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VBJR052502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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
• Patient Sex: Female