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

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6 b13: additional information in regard to the event and images of the case were requested from the corresponding author.H6 b14: a review of the manufacturing records was not performed because the serial number is unknown.H3 and h6 code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.C1: 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

Within this article: "the combination of vacuum-assisted thromboaspiration and covered stent graft for acute limb ischemia due to thromboembolic complications of popliteal aneurysm" published by gianmarco de donato et al annals of vascular surgery, volume 89, 2023, pages 232-240; february 2023, published online: 26 september 2022.According to a report published by gianmarco de donato, md, phd et al.2022, use of the ¿viabahn covered endografts¿ [gore® viabahn® endoprosthesis] as evaluated in patients with a diagnosis of paa [popliteal artery aneurysm] complicated by thromboembolic events undergoing total endovascular rescue and were prospectively enrolled in a dedicated database from november 2018 to november 2021.In a total population of 17 male patients, patients received viabahn covered endografts for treatment of popliteal artery aneurysm.Medical histories of the study patients included hypertension, diabetes mellitus, dyslipidemia, chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, atrial fibrillation, smokers, former smokers, history of malignancies, and cerebrovascular disease.It was reported that all patients are routinely checked at 1- and 6-month follow-up, and yearly with a clinical visit and dus [doppler ultrasound] examination.Restoration of direct perfusion to the foot was achieved in 16 cases (94.1%).In all cases, the revascularization procedure allowed to increase the number of tibiopedal outflow vessels of at least 1, assuring the direct foot perfusion.Neither intraprocedural distal embolization nor any other intraprocedural serious complications occurred.Fasciotomy was performed only in 1 case.One access complication was detected: a femoral pseudoaneurysm resolved by percutaneous injection of thrombin.No cases of hemolysis occurred; blood transfusion was necessary in 1 case.Hospitalization reocclusion occurred in only 1 case leading to above-the-knee amputation due to the severe and progressive ischemic gangrene and foot infection.Only 1 death was registered (no paa-related).Survival rates at 6, 12, and 24 months were respectively 94.1%, 86.3%, and 67.9% six (35.3%) reinterventions were performed: 1 for a proximal paa endoleak treated with the implantation of proximal extension using a covered endograft 1 for a proximal paa endoleak treated with the implantation of proximal extension using a covered endograft.5 for acute endograft reocclusion treated with further thromboaspiration or femoropopliteal bypass.Secondary patency was achieved in all cases (100%).During follow-up, 1 btk [below the knee] amputation was performed 3 months after the index intervention due to an aggressive infection of the foot unresponsive to antibiotic therapy.Our protocol of paa urgent revascularization includes the total endovascular aneurysm exclusion using the viabahn endograft.Our experience reported good early and mid-term limb salvage outcomes even if the reintervention rate is significant.Most reinterventions were due to acute reocclusion that was promptly treated using both surgical or redo-endovascular thromboaspiration, with high secondary patency.Further details regarding the gore® viabahn® endoprosthesis were not provided.

Manufacturer Narrative

H6: corrected imdrf codes.

Manufacturer Narrative

Multiple attempts were made to obtain further details from corresponding author.No response was received.H6 - code b20/22: device lot/serial numbers were not provided to conduct manufacturing record history review.No devices (if any explants) were returned for investigation.Ifu for gore® viabahn® endoprosthesis; gore® viabahn® endoprosthesis with propaten bioactive surface.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: vessel thrombosis, occlusion, malapposition; device related: complications and adverse events can occur when using any endovascular device.These complications include, thrombosis or occlusion; b3: date of event - online publication date was used.B4: event description was updated.B7: patient population co-morbidities were listed (based on article information).D2a/2b: correction made to produce code and common device name.E1: physician phone number was added.G4: pma/510(k)number was corrected.Article citation: the combination of vacuum-assisted thromboaspiration and covered stent graft for acute limb ischemia due to thromboembolic complications of popliteal aneurysm.Authors gianmarco de donato et al.Annals of vascular surgery, volume 89, 2023, pages 232-240; february 2023, published online: 26 september 2022.Article was attached.H6 - investigation conclusion codes were updated.

Event Description

Article reviewed: the combination of vacuum-assisted thromboaspiration and covered stent graft for acute limb ischemia due to thromboembolic complications of popliteal aneurysm.Authors gianmarco de donato et al.Annals of vascular surgery, volume 89, 2023, pages 232-240; february 2023, published online: 26 september 2022.Article states, from november 2018 to november 2021.A prospective enrolled patient study with 17 male patients was done.Popliteal artery aneurysms (paa) were treated using gore® viabahn® endoprosthesis (viabahn device) with acute limb ischemia and complicated by thromboembolic events.All patients were admitted in urgent/emergent setting.Mechanical thrombectomy (indigo penumbra thrombo-aspiration system) was performed in all patients prior to implanting viabahn devices.Paas were excluded using one to three viabahn devices in patients.Technical success during implant procedures was 94.1% (16 patients); fasciotomy was performed only in 1 case.During mean follow-up of 17.6 +/- 9.2 months, survival rates at 6, 12, and 24 months were respectively 94.1% (1 case), 86.3%, and 67.9%.Hospitalization re-occlusion occurred in only 1 case leading to above-the-knee amputation due to the severe and progressive ischemic gangrene and foot infection.One proximal paa endoleak treated with covered stent implant for proximal extension.

• 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: 16929166
• MDR Text Key: 315194128
• Report Number: 2017233-2023-03926
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 10/16/2023

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: 04/26/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 04/26/2023; 10/13/2023
• Supplement Dates FDA Received: 10/10/2023; 10/16/2023
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Male