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 Pain (1994); Obstruction/Occlusion (2422)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient called with questions about mri for previously implanted visipro stent.Patient reported having an mri in (b)(6) of 2019 and having a searing pain in the stent area and mri had to be stopped.The patient reports having pain in the area a few days later and after consulting physician it was found that her sma artery was occluded.The patient had to have another stent implanted.A non-medtronic (gore viabahn) stent was implanted.The patient was given mri information for the visi-pro stent.No further injury reported.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12728921
• MDR Text Key: 282840203
• Report Number: 2183870-2021-00397
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/01/2021

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
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention