MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-06-27-080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an attempt to treat a lesion in the left hypogastric artery using a visi pro stent, the stent could not cross the lesion successfully.It was reported that the lesion was pre-dilated and that no embolic protection was used.It was reported to be moderately calcified, 10-15 mm in length and with a diameter of 6mm.The physician reported encountering resistance while advancing the device and that no excessive force was used.It was reported that the physician removed the entire delivery system.Deformation of stent was noted once the visi-pro had been removed from the patient and was on the table.It was reported that the device tip component was damaged while attempting to deliver the stent through the vessel.An everflex 7x20mm stent was used to complete the procedure.It was reported that there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6431024
• Report Number: 2183870-2017-00144
• Device Sequence Number: 986717
• Product Code: FGE
• UDI-Device Identifier: 00821684036310
• UDI-Public: 00821684036310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• 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,Followup
• Report Date (Section B): 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2019
• Device Catalogue Number: PXB35-06-27-080
• Device Lot Number: A329256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR