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

Catalog Number PAJR081002B

Device Problems Complete Blockage (1094); Appropriate Term/Code Not Available (3191)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

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.Devices remain implanted; therefore, direct product analysis was not possible.(b)(4).The images received could not be used to perform a full imaging evaluation because they do not meet the dicom standard.Therefore, the extent and accuracy of the observations and findings were limited due to the completeness, format and/or quality of the items provided for review.Evaluation of the reported failure modes could not be conducted with the items returned for review, and there were no pre-implant images provided.Noted during evaluation: it appears that the viabahn® device may be deployed in a vessel smaller than recommended vessel diameters.There is an area of irregularity noted within the viabahn® device, but there is minimal imaging provided and this provides no ability to assess the steps related to deployment or the catheter removal.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface warnings.W.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.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.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, a patient presented with flank pain.During the intervention, bleeding was observed from spleen varices because of sinistral hypertension.The objective was to open the splenic vein to alleviate the pressure and stop the bleeding.Under ultrasound guidance a branch of the splenic vein was accessed using a 21g needle.A mandrel wire was advanced into the splenic vein, then a transitional dilator was inserted.Venogram showed distal splenic vein occlusion with drainage towards the portal cavernoma via numerous adjacent collateral vessels.Over a 6fr guidewire, an 11cm slender sheath was advanced into the splenic vein.Suspected splenic vein stump draining towards the portal confluence was cannulated using a 4fr impress catheter, a 0.018'' advantage guidewire and a cxi crossing catheter.The advantage guidewire and cxi crossing catheter were advanced through the superior mesenteric vein occlusion and partially into the main portal vein.The 6fr sheath was then exchanged for a 7fr 11cm sheath.Angioplasty of the splenic vein and portal venous occlusion was performed using a 4x100mm balloon, a 4x40mm, then a 4x20 athletis¿ ultra high pressure balloon.From the splenic access, an 8mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) was advanced to the level of occlusion.The vsx device would not go beyond the occlusion, so it was deployed at this location.Reportedly, the device fully expanded.During removal of the delivery system, the delivery catheter could not be removed from inside the sheath.Different troubleshooting techniques were used to remediate the situation, including balloon angioplasty, a larger sheath for retrieval, forward and backward catheter manipulation.Eventually, a snare was advanced through the vein access to capture the distal tip.Two physicians then manipulated the delivery system, with one pulling on the snare, and the other pulling on the proximal end of the delivery system.The delivery catheter was able to be removed in one piece and procedure continued.A protégé self expanding stent was deployed distal to the viabahn device in an overlapping fashion.The stent was deployed at the level of the focal stenosis at the confluence of the splenic vein and the superior mesenteric vein.The left portal vein was dilated using an 8mmx80mm balloon.The stenosed area was further covered with another viabahn device (8mm x 5cm) at the level of the confluence.Two other stents (bms) were then deployed in the right and left portal veins and post-dilated.Angiogram revealed thrombus had formed in all the indwelling stents with occlusion at the level of the proximal vein.The stents were then further dilated with an angioplasty balloon.10mg tpa was injected through the splenic access and into the right portal vein.An additional 10mg of tpa was injected into the hepatic venous access into the left portal vein.Patency was restored.Upon follow-up the patient is doing well.The physician is unsure of what caused the catheter retrieval difficulty.Vsx device image seem to indicate mid-stent is not smooth and the struts do not appear to fully appose the vessel wall.If this is the case, the difficulty may be associated with the patient¿s anatomy, from the transition to the patent splenic vein and the occlusion.In retrospect, the physician stated he should have used a longer sheath to protect the vsx device(s) for deployment.Because patient presented with bleeding, heparin was not administered during the procedure.However, tpa was given because subsequent stents were deployed (bms).The physician stated he will consider giving heparin in these types of cases in the future, because they can always reverse the heparin, and it would prevent stent thrombosis.

Manufacturer Narrative

B1: both adverse event and product problem were checked.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16079287
• MDR Text Key: 306444569
• Report Number: 2017233-2022-03610
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAJR081002B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male