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

Catalog Number	PXB35-08-17-080
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a visi pro balloon expandable stent during treatment of a 20mm plaque lesion in the patient¿s proximal common iliac artery of diameter 8mm.Moderate tortuosity and calcification were reported.The ifu was followed and the device was prepped without issue.Pre-dilation was carried out using a size 5 pre-dilation device.No embolic protection was used.The device did not pass through a previously deployed stent, no excessive force was used but resistance was experienced.It was reported that stent dislodgement occurred in vivo during positioning as the stent came off the balloon.The stent was deployed in the intended lesion in the patients iliac using another pta.

• 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: 8132386
• Report Number: 2183870-2018-00562
• Device Sequence Number: 1448383
• Product Code: NIO
• UDI-Device Identifier: 00821684036464
• UDI-Public: 00821684036464
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 03/12/2021
• Device Catalogue Number: PXB35-08-17-080
• Device Lot Number: A611833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/05/2018
• 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: 83 YR