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

Catalog Number PAHR081002E

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

H6 code e2402: used to cover patient presented with 'cold leg'; likely due to reduced blood flow.H6 code b20: the device remains implanted and was therefore not available for engineering evaluation.H6 code c19: a review of the manufacturing records indicated the device met pre-release specifications.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu): w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with heparin bioactive surface in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.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) 2023, the patient underwent endovascular treatment using two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) for exclusion of popliteal artery aneurysms (paa) in the popliteal artery right leg.The procedure was completed without any issues.It was reported that on november 9, 2023, the patient was experiencing symptoms of a cold leg.They noticed that the viabahn devices migrated more than 10mm into an the aneurysm sack.On november 10, 2023, the patient received thrombolysis and a reintervention was performed where a gore® propaten® vascular graft was placed bellow the right knee.Outflow to the lower right left was restored.It was reported that the patient tolerated the procedure.

Manufacturer Narrative

H6: investigation conclusion code d16 was removed and code d15 and d12 were added.Updated ifu statement to: the vsx device ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified as related to the failure mode(s) in this complaint: adverse events: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis or in any endovascular procedure and require intervention include, but are not limited to: ¿ migration.

Manufacturer Narrative

Conclusion codes remains unchanged.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ three time-points available for evaluation: pre-implantation cta dated (b)(6) 2023, post-implantation cta dated (b)(6) 2023, and an angiogram dated (b)(6) 2023.¿ pre-implantation imaging shows the following in comparison with the post-implantation cta set of imaging: o after viewing the post-implantation imaging the treated area begins ~92cm distal to the right sfa/profunda bifurcation.O the proximal 4cm of right sfa diameters range from ~7mm -9.2mm.¿ post-implantation cta imaging shows: o the length from the right sfa/profunda bifurcation to the level of the proximal end of the proximal viabahn is ~92cm.O flow appears to stop ~26cm distal to the right sfa/profunda bifurcation.O from this level through the implanted devices and distally, there appears to be device and native vessel occlusion.O the length of the implanted stents appears to be ~17cm.Overlap of devices appears to be ~1.6cm.Most of the distal stent appears to be in the aneurysm sac.¿ angiogram dated (b)(6) 2023 shows that the stents appear to be floating in the aneurysm sac.Thereby, confirming device migration >10mm.

Manufacturer Narrative

B1: this event is an product malfunction that lead to a serious injury.Hence, both adverse event and produce problem check boxes need to be selected.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18306280
• MDR Text Key: 330221539
• Report Number: 2017233-2023-04466
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAHR081002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male