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

Catalog Number	PXB35-08-17-080
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	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a visi-pro balloon expandable stent to treat a 2 mm plaque lesion with moderate calcification in the proximal celiac artery.The lesion had 90% stenosis.The vessel was 6 mm in diameter and 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 sheath.It was reported that the physician experienced difficulty in advancing the device and the stent did not pass through a previously deployed stent.No excessive force was used.The visi-pro stent would not advance through the lesion and the physician immediately pulled the stent back into the sheath and the stent came off.It was reported that the undeployed stent was taken out along with the sheath and the procedure was completed using a new 6x90 sheath and a new stent 6x27 visi-pro balloon expandable stent.No patient injury was 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: 6978921
• Report Number: 2183870-2017-00466
• Device Sequence Number: 648832
• Product Code: FGE
• UDI-Device Identifier: 00821684036464
• UDI-Public: 00821684036464
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2020
• Device Catalogue Number: PXB35-08-17-080
• Device Lot Number: A426960
• 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
• Patient Age: 83 YR