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

Catalog Number	PXB35-07-27-080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection: the visi-pro showed the stent loaded over the balloon.One of the distal struts of the stent was stretched out in the distal direction.No fracture was noted.No other damages to the visi-pro device was observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a visipro with a non-medtronic 6fr sheath (cordis) and 0.035 guidewire (magic torque) to treat a plaque lesion with 90% stenosis in the left proximal renal artery.The artery diameter was 7mm and the vessel presented moderate tortuosity.Ifu was followed and the device was prepped with no issues noted.It was reported that the physician encountered difficulty when attempting to cross the stenosis.Plain old balloon angioplasty (poba) was used to pre-dilate the vessel.On second attempt, the stent could not make the 90 degree turn, so the catheter was removed.A 6x17 stent was used and during insertion.A shadow was noted on the guidewire.The previously used stent catheter was checked and the stent was missing.In the process of pulling the wire back, the stent came off the wire and was free floating in the aorta.An amplatz snare was inserted and removed the stent in its entirety.The procedure was not completed.When the device was returned to the manufacturing facility, it was noted that the stent was damaged.

• 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: 8435821
• Report Number: 2183870-2019-00137
• Device Sequence Number: 2227912
• Product Code: NIO
• UDI-Device Identifier: 00643169787773
• UDI-Public: 00643169787773
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/20/2019

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: 11/12/2021
• Device Catalogue Number: PXB35-07-27-080
• Device Lot Number: A739616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/20/2019
• 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