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

Catalog Number	PXB35-08-17-135
Medical Device Problem Codes	Device Slipped (1584); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a visi-pro balloon-expandable stent with 6 fr non-medtronic sheath and a 0.035 non-medtronic guidewire for the treatment of a 10mm moderately tortuous, calcified plaque lesion in the proximal right common iliac artery of diameter 8mm.Lesion exhibited (b)(4) stenosis.Embolic protection was not used.Ifu was followed and device was prepped without issue.Lesion was not pre-dilated.Device passed through a previously deployed stent.No resistance was encountered and no excessive force was used.It was reported that stent dislodgement occurred during its delivery to the lesion.The physician was successful in recapturing the stent over the original balloon by inflating and could advance to the lesion site.The stent was then successfully deployed at correct site.No patient injury 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: 6837229
• Report Number: 2183870-2017-00367
• Device Sequence Number: 1522130
• Product Code: FGE
• UDI-Device Identifier: 00821684036471
• UDI-Public: 00821684036471
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 08/02/2017

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: 10/11/2018
• Device Catalogue Number: PXB35-08-17-135
• Device Lot Number: A172046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1