MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Catalog Number	PXB35-07-37-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.The stent of the visi-pro stent delivery system was received slid proximally approximately 22mm.One of the distal stent hoops is bent proximally over the stent.One of the proximal stent hoops is bent upward from the stent delivery system.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 moderately tortuous and moderately calcified left proximal common iliac artery lesion exhibiting 95% stenosis.A non-mdt guidewire was used.Embolic protection was not used.The device was removed from its packaging and inspected with no issues noted.The ifu was followed during the procedure.It was reported that as the physician attempted to advance the device towards the lesion, it could be seen under fluoroscopy that the stent was beginning to migrate on the balloon.The physician was able to successfully remove the stent over the wire and through the sheath with no further migration and no injury to the patient.The physician replaced the device with another visi-pro stent and completed the procedure without further complications.

• 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: 7239181
• Report Number: 2183870-2018-00058
• Device Sequence Number: 16177962
• Product Code: NIO
• UDI-Device Identifier: 00821684036426
• UDI-Public: 00821684036426
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/02/2018

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: 11/12/2020
• Device Catalogue Number: PXB35-07-37-080
• Device Lot Number: A555070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1