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

Catalog Number	PXB35-07-17-135
Medical Device Problem Codes	Difficult To Position (1467); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was attempting to use a visi-pro stent to treat a plaque lesion with moderate calcification in the proximal renal artery.The lesion resulted in 90% stenosis and the vessel was moderately tortuous.The device was prepped as per the ifu with no issues noted.The lesion was not pre-dilated.The procedure used a 6x70 non-medtronic sheath, 0.035" non-medtronic guidewire and a left brachial approach.No embolic protection was used.The stent did not pass through a previously deployed stent.It was reported that the visi-pro would not advance through the lesion and the physician immediately attempted to pull the stent back into the sheath once he encountered resistance.No excessive force was used.The stent fell off the balloon catheter and the physician was unable to pull it back into the sheath.The physician was able to thread a 4x20 pta balloon through the stent and open it, although it was not in the target area.Another visi-pro stent was implanted at cover the lesion site.No patient symptoms or complications were reported.

• 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: 6978731
• Report Number: 2183870-2017-00465
• Device Sequence Number: 10957745
• Product Code: FGE
• UDI-Device Identifier: 00821684036396
• UDI-Public: 00821684036396
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 03/30/2020
• Device Catalogue Number: PXB35-07-17-135
• Device Lot Number: A438177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/25/2017
• 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: 63 YR