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

Catalog Number PAHR061002E

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 09/06/2022

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for in-stent restenosis located in the left superficial femoral artery (sfa) defined as beginning at the origin of the sfa and ending at least 1 cm above the intercondylar notch as verified by imaging.Before gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device) placement pre-dilation was performed.A vsx-device was implanted successfully.No additional procedures were performed at treatment.The vsx-device was patent, and the patient tolerated the procedure.On (b)(6) 2022, a total vessel occlusion of the left study limb was determined.An endovascular reintervention, namely a thrombolysis on the study limb was performed on (b)(6) 2022.The vsx-device patency was restored at the end of the procedure and there were no procedural complications.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient identifier reflect the study no.With hospital and patient.Product history review: a review of the manufacturing-, heparin coatings- and sterilization records indicated that the lot met all pre-release specifications.As the device remains implanted, a further investigation cannot be performed.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

Images were requested and received from the hospital and an imaging evaluation performed.Summary: the imaging evaluation performed by a clinical imaging specialist showed the following: intra-operative angiogram imaging dated (b)(6) 2022 shows a portion of the left sfa is occluded.Two stents are implanted, and occlusion remains.Final angiogram run shows the left sfa and stents are patent.Post-implantation cta dated (b)(6) 2022 shows occlusion in the implanted stents.The total length of the implanted stents appears to be ~98mm.Left sfa just proximal to the stents including vessel occluded distal to the stents appears to be ~16cm.There is significant calcium proximal to the implanted stents in the left sfa.Diameters within the section of stent overlap appears to be ~2.6mm.Angiogram for thrombectomy on (b)(6) 2022 shows the occlusion starting just proximal to the implanted stents in the left sfa.Thrombectomy procedure shows restoration of flow into the implanted stents on this time-point.Can only confirm flow to the level of the distal end of the implanted stents with available imaging on this time-point.Angiogram performed on (b)(6) 2022 shows flow is restored throughout the implanted stents and distal to the stents within native vessels.The physician stated that he thinks that a proximal dissection/small thrombus (which was not visible at completion angiography) was the reason for early occlusion.It seems not related to gore® viabahn® endoprosthesis with propaten bioactive surface.With the information provided to gore, the root cause of the reported event cannot be established.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: thrombosis, occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15586232
• MDR Text Key: 301642483
• Report Number: 2017233-2022-03396
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR061002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male