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

Catalog Number PAJR071002E

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation of the device cannot be performed.Further information related to the event and patient comorbidities were requested as well as radiographic images for evaluation.Cbas® heparin surface incorporates cbas-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

A study alert was received from viedoc database.The following was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for a de novo lesion in the external iliac artery as verified by imaging.A gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device) was implanted in the external iliac artery (eia) in the right leg.Pre- and post-dilation was performed in the eia.At the end of the procedure the device was patent.The patient tolerated the procedure.As additional procedure an absolute pro 8 x 120 bare metal stent was implanted in the common iliac artery.On (b)(6) 2022, an in-stent restenosis of the right study limb was diagnosed.Therefore, an endovascular reintervention including antiplatelet / anticoagulant medication was performed on (b)(6), 2022.At the end of the procedure the vsx-device patency was restored and there were no procedural complications.

Event Description

The following was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment for an occlusion in the common iliac artery (cia) and the external iliac artery (eia) as verified by imaging.It was stated that the cia was treated with a balloon expandable restorer stent system from ivascular and the eia with an absolute pro¿ vascular self-expanding stent system from abbott.During the postdilatation of the absolute pro stent, a perforation occurred (eia) and a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx-device) was implanted with good final result.It was reported that on (b)(6) 2022, the patient was presenting with a rethrombosis of the right iliac access (cia & eia).On (b)(6) 2022, he was treated by rotarex to remove the clot: underlying lesion was noticed at the previous implanted restorer and in the superficial femoral artery (sfa).The cia was retreated with a begraft, the sfa with a drug coated balloon (dcb).Unfortunately, there was also distal embolisation in the tibial arteries, treated by thrombusaspiration and additional plain old balloon angioplasty (poba).The vsx-device (in the absolute pro stent) in the eia was doing fine post recanalisation.

Manufacturer Narrative

B5 was updated due to further information received from the study investigator.As the device remains implanted, no further investigation of the device can be performed.No clinical images enabling direct assessment of product performance were returned for evaluation.H6 evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing- and heparin coatings records indicated the device met pre-release specifications.The study investigator stated that the reason for re-thrombosis was probably a technical issue with the restorer/cia and/or a missed outflow lesion in the sfa.No relationship with comorbidities of the patient.The reported event appears not to be vsx-device related, but potentially restorer device related and/or most suggestive operator related.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 PROPATEN 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: 14741906
• MDR Text Key: 294852724
• Report Number: 2017233-2022-03019
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 07/28/2022

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
• Device Catalogue Number: PAJR071002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 62 KG