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 Myocardial Infarction (1969); Thrombus (2101); Rupture (2208); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance medtronic¿s paramount mini and visi pro balloon expandable stent systems.Survey results received for an interventional cardiologist with 29 years¿ experience who was been using the paramount mini stent system since 2019 and the visi pro stent since 2016.The respondent utilized the visi pro mini stent system in 320 procedures were carried out using the visi pro stent system to treat lesions believed to be at high risk of stenosis following pta in the common iliac arteries, with 102 of these being undertaken in last 12 months.299 procedures were carried out using the visi pro stent system to treat lesions believed to be at high risk of stenosis following pta in the external iliac arteries, with 106 of these being undertaken in last 12 months.For palliative treatment of malignant neoplasms in the biliary tree, the physician has performed 149 procedures using the visi pro stent system, with 20 of these being carried out within the last 12 months.The respondent reported device related complications of cardiovascular events, intraluminal thrombus associated with peripheral interventions.The cardiovascular event was reported to be very concerning and the intraluminal thrombus was considered to be somewhat concerning.The respondent reports a complication of allergic response in persons with known allergic reactions to 316l stainless associated specifically with pta or stent placement for occlusive or stenotic disease.This event was deemed to be device related and considered to be somewhat concerning.The respondent reported complication of rupture resulting from overstretching the duct associated specifically with biliary interventions during use of the visipro device.In this case stent has undergone excessive self-expansions leading to rupture of the ducts.

• 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 ; 091708734
• MDR Report Key: 9444531
• MDR Text Key: 170851344
• Report Number: 2183870-2019-00568
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/10/2019

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: 12/03/2019
• Initial Date FDA Received: 12/10/2019
• 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