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

Catalog Number	PXB35-08-37-080
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician intended to use a visi-pro balloon expandable stent with a 6fr cordis 15 cm sheath and cordis aquatrack guidewire for the treatment of a 60 mm moderately calcified, severely tortuous fibrous lesion in mid/ distal location in the left common iliac artery of diameter 8 mm.Lesion exhibited cto (chronic total occlusion-100%).Embolic protection was not used.The device was prepped as per ifu without issue.It was reported that during removal, following failed delivery of the device, stent dislodgement occurred.The dislodged stent was not removed.An additional stent (protégé 7 mm x 40 mm) was used to push against the arterial wall.Lesion was pre-dilated using a 5 mm pre-dilation device.The protégé 7 mm x 40 mm device was passed through the dislodged visi-pro stent to scaffold and secure the stent against the arterial wall with resistance encountered requiring excessive force for delivery.No further 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: 6692872
• Report Number: 2183870-2017-00293
• Device Sequence Number: 531464
• Product Code: FGE
• UDI-Device Identifier: 00821684036501
• UDI-Public: 00821684036501
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/08/2017

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: 02/09/2020
• Device Catalogue Number: PXB35-08-37-080
• Device Lot Number: A412540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/07/2017
• 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: Other