MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Obstruction of Flow (2423)

Patient Problem Thromboembolism (2654)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Patient age and gender provided in the article: patient age: 74 = mean age; patient gender: vast majority is male.Date of event is unknown, so the date the manuscript was accepted was used as date of event.Complainant phone number cannot be obtained.The device(s) remain(s) implanted in the patient.

Event Description

The following literature article was reviewed: "endovascular treatment of chronic occluded popliteal artery aneurysm: early and mid-term outcomes" vincenzo ardita et al.Journal of cardiovascular surgery 2018;59:405-11.Manuscript accepted: july 24, 2017.Article first published online: july 24, 2017.The literature article presents a retrospective analysis of a study, conducted from may 2011 to april 2015, including 1115 patients who underwent endovascular repair.Among this cohort, 25 patients (23 male, mean age of 74.4±10.5 years) presented with chronic occlusion of popliteal artery aneurysms (paa, segments p1 ton p3) with diameter >20 mm (rutherford-becker categories 4 to 6) were analyzed.The primary study endpoints assessed were the 1- and 3-year stent-graft primary and secondary patency, which were 79% and 73,3; 85.8% and 79,7%; 79% and 73.3%, respectively.In total 6 occlusions of stent grafts occurred.Procedure: ten patients underwent standard endovascular popliteal aneurysm repair (evpar) using only self-expandable stent grafts, whereas in 15 patients a combination of covered stent graft and bare metal stent (bms) was performed.In 9 patients the lesions were above knee, in 6 patients below knee and in 10 patient the lesion crossed the joint line.In total 14 covered stent-grafts used with evpar (viabahn (w.L.Gore & associates), and/or advanta v12 (atrium medical corporation).Percutaneous access was performed in 80% of patients.The distal true lumen was achieved by an antegrade approach in 96% of patients.One patient required an anterior tibial artery retrograde approach to cross the target occluded aneurysm.The distal landing zone of the stent graft was at segment p2 in 7 patients and at segment p3 in 18 patients.Viabahn stent-grafts of appropriate diameter (5-11 mm), which were oversized by 1 mm, were employed exceeding proximally and distally the landing zone of =15 mm.Multiple stents were required for long aneurysms or in the event of a significant size mismatch between the proximal and distal landing zone.The article includes the following case: 12 days after intervention one stent-graft occlusion with peroneal embolization occurred, requiring thrombectomy and balloon stent-graft implantation.

Manufacturer Narrative

H6-code 3221: several attempts were made to obtain additional information like patient information, lot number, detailed event description, dicom images, date of implant and reintervention.The information was not disclosed to gore.Without additional information, gore was unable to do further investigation of this event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9124413
• MDR Text Key: 164106957
• Report Number: 2017233-2019-00927
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR