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 Stroke/CVA (1770); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis (2263); Vascular Dissection (3160); Unspecified Tissue Injury (4559)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

Journal title: self-expanding versus balloon-expandable stents for iliac artery occlusive disease - the randomized ice trial jacc: cardiovascular interventions vol.10, no.16, 2017 ¿ 2017 by the american college of cardiology foundation published by elsevier issn 1936-8798/$36.00.Http://dx.Doi.Org/10.1016/j.Jcin.2017.05.015.Age: average.Sex: majority.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study of patients who were treated for iliac artery occlusive disease with balloon-expandable stent (be) or self-expanding stent (se).The article reports comparison of treatment with se stents as compared with be stents.660 patients were included in the study.Medtronics visipro stent was used in the population of patients who received a be stent.Medtronics prot¿g¿ stent was used in the se group.Periprocedural complications were reported in both the se and be groups with most reported as being minor bleeding events at the access site or occurred due to perforation or dissection.Complications in the se group include bleeding/hematoma/false aneurysm/low hemoglobin level, dissection, perforation, hypotension, renal failure, and also a distal embolization occurred and could be resolved during the index procedure.Three of the patients with embolization were treated due to an occlusion and 1 of them was treated due to an in-stent restenosis.Thus, occlusions or in-stent restenosis were more frequently affected by distal embolization than restenosis.Within the be group complications of bleeding/hematoma/false aneurysm/low hemoglobin level, dissection, perforation, and arterioveno us fistula described as a post-interventional shunt between common femoral artery and femoral vein.At 6-month follow-up target lesion revascularization (tlr), restenosis, walking impairment, and stroke is reported in both the se and be groups.All cause death is reported in both se and be groups.Target limb amputation is reported in the in the be group.A mave (major adverse vascular event) is reported in the se group.At 12-month follow-up tlr, tvr, restenosis, walking impairment, all cause death, stoke and mave are reported in the be and se groups.Target limb amputation is reported in the in the be group.Cause of death across the population is reported as mi, cardiogenic shock, cerebral aneurysm, sepsis, pneumonia, multiple myeloma and unknown reasons.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11782464
• MDR Text Key: 249229452
• Report Number: 2183870-2021-00162
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 12/01/2020
• 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: 64 YR