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

Catalog Number	PXB35-06-17-135
Medical Device Problem Codes	Difficult To Position (1467); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was attempting to use a visi-pro balloon expandable stent to treat a 15mm severely calcified lesion in the right proximal renal artery (90% stenosis).The artery had a diameter of 7 mm and had little tortuosity.The device was prepped as per the ifu with no issues identified.The procedure used a 10 fr sheath and a 0.035" guidewire.The vessel was pre-dilated using a 4x20x80 predilation balloon.Resistance was encountered advancing the device.The visi-pro stent did not pass through a previously deployed stent and no excessive force was used.It was reported that the stent failed to cross the lesion and stent dislodgement occurred.The stent was snared with no reported issues.The procedure was completed using a paramount-mini stent.No patient injury was reported.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7239278
• Report Number: 2183870-2018-00060
• Device Sequence Number: 13710253
• Product Code: NIO
• UDI-Device Identifier: 00821684036303
• UDI-Public: 00821684036303
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2020
• Device Catalogue Number: PXB35-06-17-135
• Device Lot Number: A467730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 98