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

Catalog Number	PXB35-05-17-080
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/12/2019
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
It was reported that the physician intended to use the visipro balloon expandable stent to treat a severly calcified severely tortous lesion in the common iliac/renal artery.There was no resistance encountered when advancing the device.The stent would not cross into the renal artery.Upon removal of the device, the stent came off the balloon as it was being retracted into the sheath.A cutdown was performed to remove the stent.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: an 8fr brite tip sheath and a 0.35x260cm wholey wire mod-j was used in the procedure.The lesion had 80% stenosis and was located in the right common iliac/renal artery.The device was prepped as per ifu with no issues identified.The lesion was pre-dilated with a 2.00mm x 150cm nanocross elite balloon.Resistance was encountered when advancing to the lesion.The device did not pass through a previously deployed stent.It was reported difficulty was encountered trying to deliver the stent over the lesion.The stent would not cross into the left renal artery.If information is provided in the future, a supplemental report will be issued.

• 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: 8266331
• Report Number: 2183870-2019-00026
• Device Sequence Number: 16674244
• Product Code: FGE
• UDI-Device Identifier: 00643169787575
• UDI-Public: 00643169787575
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/04/2019

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: 10/17/2021
• Device Catalogue Number: PXB35-05-17-080
• Device Lot Number: A726189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019; 02/12/2019; 04/03/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 01/23/2019; 03/07/2019; 04/04/2019
• 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