MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA077901J

Device Problem Device-Device Incompatibility (2919)

Patient Problems Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 09/05/2022

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.Patient identifier, age and/or dob, gender, weight, relevant medical history including medications, were requested but not made available.Device lot/serial number was requested, but not made available.Therefore, review of device manufacturing record history could not be conducted.The detached/displaced stent ring was explanted, but was not returned to gore for evaluation.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 was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for bilateral external iliac arteries using gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).Reportedly, perclose proglide¿ was used for hemostasis of the access vessel after the implantation.On (b)(6) 2022, during another endovascular treatment for a peripheral arterial disease (pad) in the right superficial femoral artery (sfa), it was observed under fluoroscopy that one row of stent ring at the distal end of the vbx device implanted in the left external iliac artery was separated from the graft.The dislodged stent ring appeared to be in an oval shape, and had migrated to the proximal left common femoral artery.After treatment in the right sfa was completed, a pta balloon was used to press/crush the loose stent ring against the patient's vessel wall.The stent ring migrated because it was entrapped by the perclose proglide¿ suture.Using digital subtraction angiography, good blood flow was confirmed from the distal left common femoral artery.On (b)(6) 2022, the patient complained of symptoms (details unknown) in the area where the dislodged vbx stent ring was pressed to vessel wall.Surgical endarterectomy and a cut-down in the left common femoral artery was performed.The stent ring was removed.Reportedly, only the stent ring was separated/dislodged, and it was easily removed.The patient was recovering well postoperatively.The physician stated the perclose proglide¿ used after the vbx device implantation likely caused this event.The perclose proglide¿ puncture site and the distal end of the vbx device were in close proximity to each other, and the perclose proglide¿ ligature operation may have entrapped the distal end stent ring, resulting in the stent ring being entrapped by the perclose proglide¿ suture.As a result, it is possible that the distal end row of the vbx stent rings was separated from the graft and moved to the vicinity of the puncture site (proximal side of the left common femoral artery).

Manufacturer Narrative

Imaging evaluation summary: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation performed by a clinical imaging specialist showed the following: one jpg image submitted for evaluation.Unable to confirm stent ring detached by accessory device; crushed against vessel then explanted at later date.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15499312
• MDR Text Key: 300734629
• Report Number: 2017233-2022-03361
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• 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,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA077901J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: PERCLOSE PROGLIDE
• Patient Outcome(s): Required Intervention