MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160); Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Medtronic received a journal article titled 'fate of asymptomatic limb after kissing stents in aortoiliac occlusive disease'.A total of 106 patients undergoing aortic bifurcation intervention from january 2015 to november 2020 were retrospectively reviewed.Only patients with at least one common iliac artery (cia) ostium and undergoing bilateral cia intervention were included in the study.Patient inclusion was limited to true aortoiliac disease at the bifurcation with involvement of at least one cia ostium up to 1 cm from the bifurcation, and bilateral kissing intervention (either balloon angioplasty or stent) was performed.All patients underwent endovascular intervention through a multidisciplinary team (mdt) review comprising vascular surgeons and interventional radiologists.The practical criteria for choosing a kissing versus single-stent approach were left to the discretion of the individual teams.In general, a kissing stent approach was selected for complex aortoiliac bifurcation lesions involving the distal aorta and bilateral ostia of cias, and asymmetric aortoiliac lesions involving the unilateral cia ostium, as per the currently accepted best practice.Vascular access was achieved through bilateral femoral artery punctures, either percutaneously or directly, if the patient underwent concurrent endarterectomy.Lesions were crossed using various methods, either luminal or subintimal, but in all cases, luminal re-entry was confirmed prior to treatment, and the lesion was treated from lumen to lumen.Medtronic balloon expandable visipro stent was used.Non-medtronic, self-expandable stents, covered stents and balloons were used.The selection of stent type and size was left to the discretion of the interventionalist.Stents were deployed simultaneously to ensure that the vessel flow and ostial integrity were not compromised during contralateral vessel treatment.All patients received maintenance antiplatelet therapy (aspirin 75 mg once daily) for at least one week before the intervention and intra-arterial heparin (50-100 iu/ kg) during the procedure.Patients who were already taking clopidogrel before the intervention continued this afterward.All procedures were performed under local anaesthesia using vascular closure devices at the end of the procedure.Completion angiography was performed in all cases.Technical success was defined as residual stenosis of =30%.Technical success was achieved in 99% of the cases, except in one where a heavily calcified occlusion could not be safely crossed.None of the patients required conversion to an open surgery.A total of 106 patients were followed for a median period of 26 months.None of the patients was lost to follow-up.The procedural mortality rate was 2% due to thoracic aortic dissection and abdominal aortic rupture, and the periprocedural in-hospital complication rate was 9%.The 30-day all-cause mortality rate was 3%.Major complications included aortic rupture (two cases) and groin pseudoaneurysm (two cases managed with thrombin injection).During the study period, 21 patients (20%) died of cardiovascular and non-cardiovascular causes.The number of patients free of recurrence-defined peripheral vascular events at 1, 3, and 5 years was 88%, 70%, and 59%, respectively.Primary and secondary patency rates were 98% and 99% at 1 year, 87% and 94% at 3 years, and 85% and 94% at 5 years, respectively.Six ischemic events occurred in patients with an asymptomatic limb, three cases were due to late (>30 days) stent thrombosis resulting from aortoiliac intervention.One patient presented with unilateral occlusion and underwent abf grafting at 6 weeks.Two patients presented with bilateral stent occlusion at 4 and 10 months.The former underwent surgical bypass, while the latter was managed conservatively due to comorbidities.The other three ischemic events in the asymptomatic limb were not related to aortoiliac intervention.All patients presented with worsening recurrent claudication due to downstream disease progression in the infrainguinal arteries, requiring surgical or endovascular intervention.Two patients underwent femoropopliteal bypass grafting at 12 and 24 months, and one patient underwent tibial angioplasty.Only one major amputation developed because of the progression of distal infrainguinal disease.

Manufacturer Narrative

Article title: fate of asymptomatic limb after kissing stents in aortoiliac occlusive disease vascular specialist international pissn 2288-7970 ¿ eissn 2288-7989 (2022) 38:07.A3 majority gender.B3 date of publication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16884819
• MDR Text Key: 314717027
• Report Number: 2183870-2023-00148
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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
• Date Manufacturer Received: 04/25/2023
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male