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

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

No further information was provided by the corresponding author.Therefore a device evaluation could not be performed.No investigation can be performed because further information was requested but, as reported to gore, could not be shared with gore.Therefore, an evaluation could not be performed.Preliminary results or conclusions are not available because investigation cannot be performed due to insufficient information.Further information related to the procedure, the incident and the patient condition was requested from the hospital but wont be provided according to the corresponding author.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

Within the article ¿midterm outcomes after endovascular repair of popliteal artery aneurysms demonstrate satisfactory patency rates and safety of stent grafts¿ published by arindam chaudhuri et al in the european journal of vascular and endovascular surgery, volume 64, october 2021, available online 25 august 2021.The following was published: popliteal endovascular repair (pevar) for popliteal artery aneurysm(paa) is an alternative to open surgery(osr) in patients with favourable anatomy.This is a retrospective analysis of a database of patients that underwent pevar from january 2010 to august 2020 using a gore® viabahn® endoprosthesis with propaten bioactive surface; the only stent graft used here for pevar.Cases were planned pre-operatively using computed tomography angiography (cta) and supplementary magnetic resonance angiography (mra)/duplex ultrasonography (dus) if required.Gore® viabahn® endoprosthesis with propaten bioactive surface were deployed via antegrade femoral access over a stiff wire, typically an amplatz super stiff guidewire (boston scientific, (b)(4)).Satisfactory placement of the stent graft, its patency, distal outflow and paa exclusion was confirmed.Post-operatively all patients received either dual antiplatelet therapy (dapt) or, if dapt was contraindicated, single apt with or without an anticoagulant.Follow up imaging consisting of dus was planned three monthly as per viabahn ifu for the first year and yearly afterwards.Primary outcomes assessed were technical success rate and primary, primary assisted, and secondary stent graft patency.Secondary outcomes included freedom from limb amputation, freedom from stent graft fracture and other endoprosthesis related complications (migration, kink, occlusion, stenosis or endoleak), and also post-pevar paa rupture.Statistical analyses were performed using minitab 19 software (minitab llc, (b)(4)).Over the study period, 104 paas were treated, with 40 osr undertaken (28 elective, 12 emergency, 90% male, mean patient age 73 years).A total of 64 paas in 56 patients were treated by pevar; mean age was 75 years, and 54 (96%) of the patients were male.Eight (14%) patients were found to have bilateral paas, four had synchronous bilateral pevar and the remaining four on separate occasions.The 30 day mortality rate was 0%.The technical success rate of stent graft deployment was 100%.At one year and five year follow up respectively, primary patency was 83% and 67%, primary assisted patency was 86% and 72%, and secondary patency was 89% and 75%.Re-interventions were performed in 13 (20%) cases after a median 4 months, including thrombolysis, thrombectomy, angioplasty, stent graft relining and osr.This suggests post-pevar complications mostly occur in the early post-operative period.The most frequent complication was stent graft occlusion affecting 11 (17%) limbs; median time to occlusion was 9 months.This compares favourably with other results of stent grafts in 75 paas, where occlusions occurred in 36%.Sixty-two of 64 (97%) of endoprostheses crossed the functional flexion-extension axis of the knee joint; stent fracture occurred in only one of 60 (1.7%) patients during the study period, 40 months after the index procedure, culminating in osr eight years later.Freedom from stent graft fracture at one year and five years was 100% and 97% respectively.The incidence of stent fracture and occlusion was minimized by instructing patients to avoid rapid flexion-extension and knee hyperflexion.There were no post-pevar paa ruptures.

Manufacturer Narrative

H6: corrected imdrf codes.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15231769
• MDR Text Key: 297952993
• Report Number: 2017233-2022-03216
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 07/21/2022; 03/20/2023
• Supplement Dates FDA Received: 10/03/2022; 03/20/2023
• 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): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male