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

Catalog Number	PXB35-07-17-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the visi-pro catheter was returned.The visi-pro was inspected and noted the stent was not loaded onto the balloon segment.The balloon did not show indication of inflation.The stent was returned, but was detached from the catheter.The balloon segment was inspected under microscope and identified crimp marks from where the stent was previously loaded.The stent was inspected under microscope.One end showed no damage or anomalies; however the other end did show one of the tantalum markers of the stent pushed in towards the middle of the stent.The struts showed signs of bending; however no fracturing of the stent was noted.Stent dislodgement was noted.The bent struts at one end of the stent indicate resistance may have been encountered.
Event or Problem Description
Physician intended to use a visi pro with a 6fr.Sheath and.035 guidewire for the treatment of a 10mm moderately tortuous, slightly calcified plaque lesion in proximal location in the renal artery of diameter 6mm which exhibited 70% stenosis.Embolic protection was not used.Device was prepped as per ifu without issue.Lesion was not pre-dilated.Resistance was encountered when advancing the device.Device did not pass through a previously deployed stent.The stent dislodged during delivery to the lesion.The dislodged stent was successfully removed as the stent only partially came off the balloon so it was able to be removed by removing the guide catheter that it was being delivered through.The procedure was successfully completed by up sizing the introducer and guide and using same size stent.No 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: 6685304
• Report Number: 2183870-2017-00283
• Device Sequence Number: 19141521
• Product Code: FGE
• UDI-Device Identifier: 00821684036396
• UDI-Public: 00821684036396
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• 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): 06/05/2017

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: 05/25/2019
• Device Catalogue Number: PXB35-07-17-135
• Device Lot Number: A283727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1