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	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the visi-pro delivery catheter was received with the balloon in a pre-inflation profile, (tightly wrapped and winged), with the balloon expandable stent still crimped to the balloon chamber.Stent struts at the proximal end of the stent were bent distally back over the stent.A 10cc water filled syringe was attached to the proximal hub luer lock of the visi-pro system and the guidewire lumen was flushed: a clear steady flow of fluid was observed exiting the distal tip of the visi-pro system.A 0.035¿ guidewire was loaded with ease through the distal tip of the visi-pro system and exited the proximal hub luer lock.The distal tip of the visi-pro catheter was examined: no signs of deformity were present on the distal end.
Event or Problem Description
The physician was attempting to use a visi-pro balloon expandable stent to treat a 20-30mm moderately calcified lesion in the left distal common iliac artery.The artery had a diameter of 7mm, was moderately tortuous and had 80% stenosis.The procedure used a 6 fr non-medtronic sheath and a 0.035" non-medtronic guidewire.The visi-pro stent was prepped as per the ifu with no issues identified.The vessel was pre-dilated using a 4x40 pre-dilation device and the device did not pass through a previously deployed stent.The device failed to cross the lesion.The lesion was the further dilated using an evercross 4x40 balloon.The sheath was exchanged for another 6 fr 30cm sheath which was advanced past the lesion.The visi-pro stent was removed from the patient¿s body and a deformity was reportedly visible on the stent.The deformity was visualized on the end of stent struts and was not seen prior to advancement.A new visi-pro stent was used to complete the procedure without further complication.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: 7111781
• Report Number: 2183870-2017-00563
• Device Sequence Number: 1156742
• Product Code: NIO
• UDI-Device Identifier: 00821684036402
• UDI-Public: 00821684036402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/12/2017

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: 06/20/2019
• Device Catalogue Number: PXB35-07-27-080
• Device Lot Number: A297106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74