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

Catalog Number	PXB35-07-27-080
Medical Device Problem Codes	Unintended Ejection (1234); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/12/2018
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
The physician attempted to use a visipro with a non-medtronic 6fr sheath and a 0.035 guidewire to treat a plaque lesion with 90% stenosis in the left proximal renal artery.The artery diameter was 7mm and the vessel presented moderate tortuosity.Ifu was followed and the device was prepped with no issues.It was reported that the physician encountered difficulty when attempting to cross the stenosis.Plain old balloon angioplasty (poba) was used to pre-dilate the vessel.On the second attempt, the stent could not make the 90 degree turn and the catheter was removed.Another 6x17 stent was used and during insertion a shadow was noted on the guidewire.The previously used stent catheter was checked and the stent was missing.In the process of pulling the wire back, the stent came off the wire and was free floating in the aorta.An amplatz snare was inserted and removed the stent in its entirety.The procedure was not completed.
Additional Manufacturer Narrative
Device evaluation: visual inspection: the visipro that showed no stent loaded was inspected.Traces of dried blood was observed on the outside of the balloon.It could not be determined if the balloon was inflated previously.Indentation to the balloon material was observed where the distal and proximal end of the stent were loaded.No damage to the visi-pro catheter was observed.If information is provided in the future, a supplemental report will be issued.

• 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: 8178526
• Report Number: 2183870-2018-00581
• Device Sequence Number: 1921069
• Product Code: NIO
• UDI-Device Identifier: 00643169787773
• UDI-Public: 00643169787773
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 11/12/2021
• Device Catalogue Number: PXB35-07-27-080
• Device Lot Number: A739616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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