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

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

This information was obtained by gore from a conference presentation (the (b)(6) endovascular symposium; (b)(6) 2022).Title of the presentation: a case of acute limb ischemia due to extensive thrombotic occlusion of eia~pop immediately after stent-graft implantation for sfa occlusion with intermittent claudication.The serial numbers remain unknown and no devices were returned.Additional information regarding the event and devices was asked, but was not made available to gore, therefore this investigation is considered complete with the information available.The patient identifier (internal gore id: (b)(4) is associated with two other devices/mdrs involved within this event.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.

Event Description

The following information was obtained by gore from a conference presentation: the patient underwent endovascular treatment for long occlusion in the right superficial femoral artery (sfa) with intermittent claudication that had appeared approximately 1 month ago using two gore® viabahn® endoprostheses with heparin bioactive surface (viabahn device).The viabahn devices were implanted from about 4-5 mm distal to the origin of the sfa.After the implantation, digital subtraction angiography (dsa) showed a suspected defect at the origin of the sfa.Thrombus aspiration was performed, but the defect was confirmed to be worsened by dsa, and ivus revealed the suspicion of residual plaque at the origin of the sfa, so a non-gore stent was implanted at the site.Dsa showed that the defect had migrated to the cfa and the lateral femoral circumflex artery (lfca) was poorly visualized.Ivus showed flattening of the proximal edge of the non-gore stent and stenosis at the distal cfa.Aspiration was performed and lcfa visual got improved but sfa became stenosed.After repeated poba, cfa stenosis improved to 50%, but a 5-6 cm stenosis appeared at the proximal sfa, so an additional viabahn device was implanted at the site.However, the sfa including the viabahn devices were poorly visualized.Poba was performed, and although there was a 50% stenosis of the cfa, the sfa became patent, so the treatment was moved to anticoagulation therapy.Pain and numbness in the right leg began at night, and the next morning, right leg paresthesia and dyskinesia appeared.Mra showed extensive occlusion from the right distal external iliac artery to p2, and all three viabahn devices showed occlusion.Emergency surgery was performed to remove the proximal and distal thrombus and a femoro-popliteal bypass.The patient was discharged 23 days postoperatively.The removed thrombus was confirmed to be a ¿hard¿ (non-collapsible) thrombus with a slightly white tone, so a plaque shift was suspected.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15396597
• MDR Text Key: 299663741
• Report Number: 2017233-2022-03304
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/09/2022
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female