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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/23/2015

Event Type  Injury  

Manufacturer Narrative

The following literature article was reviewed: "three-year outcome of the heparin-bonded viabahn for superficial femoral artery occlusive disease" bahar golchehr et al.Journal of vascular surgery, j vasc surg 2015;62:984-9 submitted mar 5, 2015; accepted apr 23, 2015 http://dx.Doi.Org/10.1016/j.Jvs.2015.04.436.Patient age: mean age 70 years.Patient gender: vast majority is male.Date the event occurred is unknown, so the date the article was accepted was used as date of event.The event involves two devices reported under mfr report numbers #2017233-2020-00288.

Event Description

The following literature article was reviewed: "three-year outcome of the heparin-bonded viabahn for superficial femoral artery occlusive disease" bahar golchehr et al.Journal of vascular surgery, j vasc surg 2015;62:984-9 submitted mar 5, 2015; accepted apr 23, 2015 http://dx.Doi.Org/10.1016/j.Jvs.2015.04.436.The aim of this retrospective study was to present the 3-year outcome of the gore® viabahn® endoprosthesis for superficial femoral artery (sfa) occlusive disease, popliteal levels p1, p2 and p3.The primary end points were the 3-year primary, primary assisted, and secondary patency rates of the device.A total of 73 sfas in 70 patients were treated with a gore® viabahn® endoprosthesis in three centers (b)(6) hospital, (b)(6); and (b)(6) hospital, (b)(6) between (b)(6) 2009 and (b)(6) 2011.The mean lesion length was 17.4 cm, and 84% were classified transatlantic inter-society consensus ii types c and d.The sfa was approached either percutaneously or by surgical cutdown.In case of a concomitant lesion in the common or deep femoral artery, an endarterectomy was performed.The stenotic section was passed with a terumo wire (terumo medical corporation) and a catheter, and a distal re-entry was made.The diseased segment was dilated, and gore® viabahn® endoprosthesis were placed from distal to proximal with minimal oversizing.The entire diseased segment was covered with the device, which were postdilated with an angioplasty balloon of the same size as the device.Twenty-four lesions (34%) were treated with one device, 23 (31%) with two devices, 25 (34%) with three devices, and 1 (1%) with four devices.In total, 149 devices were used, of which 9 (6%) had a diameter of 5 mm, 116 (78%) had a diameter of 6 mm, 22 (15%) had a diameter of 7 mm, and 2 (1%) had a diameter of 8 mm.Concomitant treatment was performed in 29 procedures (39%), consisting of endarterectomy of the common femoral artery (n = 13), angioplasty of the iliac arteries (n = 7), angioplasty of the popliteal artery (n = 3), endovascular abdominal aneurysm repairs (n = 2), surgical débridement of an ulcer (n = 2), and toe amputation (n = 1); one subject was treated with thrombolytic therapy because of preprocedural crural thrombosis.Within the article it was reported, that in five cases, early occlusion occurred, of which four were successfully treated with thrombolytic therapy, and one received a surgical bypass.

Manufacturer Narrative

Code 3221: the requests to the author remained unanswered.The lot numbers remain unknown.Without additional information, gore was unable to do further investigation of this event.For this literature three medwatch reports have been transmitted: mfr report # 2017233-2020-00288 (gore # 45022).Mfr report # 2017233-2020-00289 (gore # 45022).Mfr report # 2017233-2020-00290 (gore # 45021).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10020228
• MDR Text Key: 194526195
• Report Number: 2017233-2020-00289
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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: 70 YR