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

Device Problems Migration (4003); Device Stenosis (4066)

Patient Problems Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2020, this patient underwent emergent endovascular treatment of a bleeding from a gastroduodenal artery stump that had been ligated due to infection after pancreatoduodenectomy using gore® viabahn® endoprosthesis with heparin bioactive surface.The device was reportedly placed from the right hepatic artery to the common hepatic artery.The patient tolerated the procedure.On (b)(6) 2021, the device patency was observed on the computed tomography angiography(cta) imaging.On (b)(6) 2022, the device occlusion was observed on the cta imaging.On (b)(6) 2022, a tendency toward straightening of the flexural morphology of the device was observed on the cta imaging.On (b)(6) 2022, the device was further straightened and a slight gas image was observed in the occluded device lumen.Prolapse of the distal edge of the device into the jejunal lumen was suspected.However, the patient's condition was unchanged and there was no evidence of re-bleeding or infection.On (b)(6) 2022, the patient was stable and the small gas in the occluded device lumen had disappeared.On (b)(6) 2023, the loss of the device was confirmed on the cta imaging.The physician reported, although not with certainty, that the device that had fallen into the jejunum might have been excreted with the stool, as no device was found anywhere in the abdomen/pelvis.There was no pseudoaneurysm formation and/or infection at the site where the device was implanted.The intrinsic hepatic artery to the common hepatic artery remained occluded, but the distal portion was revascularized by collateral channels, and hepatic arterial blood flow was fine.As reported, it is possible that the vessel diameter was measured as undersized under the shock condition, and after device implantation, blood flow was restored and the vessel diameter became larger, resulting in device migration into the intestines from the vessel that had become weak due to pancreatic juice and other factors.

Manufacturer Narrative

E2402: device moved from treatment area.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

H6 evaluation codes: added c0701 - device migration.A review of the device manufacturing records could not be completed because the device serial number is not known.The device serial number was requested but not provided.Image evaluation: the images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot make conclusions or guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The reported occlusion, which was reported to have occurred between 11 and 17 months following implant of the gore® viabahn® endoprosthesis with heparin bioactive surface, was confirmed through evaluation of the provided clinical images.The cause for the occlusion could not be established with the available information.The findings of the imaging evaluation are also consistent with the reported change in device shape, and indicate the device was unable to be found in the second provided video.The clinical images are not dated, with the exception of the image in the first video file, so confirmation of the specific sequence of events could not be established with the available information.The physician reported that the vessel where the device was implanted was fragile due to the prior pancreaticoduodenectomy, and this may have contributed to the observed endoprosthesis straightening and eventual migration.The reported information also indicates the gore® viabahn® endoprosthesis with heparin bioactive surface may have been inadvertently undersized because of the patient condition at the time of original implant, but there are no data to enable an assessment of device size selection.The cause for the change in device shape and subsequent vessel injury in the form of device migration into the jejunal lumen are considered to be related to the patient condition as reported.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16665979
• MDR Text Key: 312540591
• Report Number: 2017233-2023-03840
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 06/08/2023

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: 03/24/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other