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

Catalog Number	PXB35-07-37-135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	HIV, Human Immunodeficiency Virus (2197)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.No ancillary devices or cine images from the procedure were received.The visi-pro system was received with sanguine residue noted on the balloon chamber and stent.The stent was still crimped to the balloon chamber.The balloon chamber was in a pre-inflation profile.Under magnification it was noted that several of the distal struts of the stent were bent proximal over the stent.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a visipro device with a 6fr sheath and 0.035 guidewire for the treatment of a calcified lesion in the right external iliac artery.The aorta was reported to be tortuous.Access was in the left auxillary artery.The lesion exhibited severe atherosclerosis.Severe occlusion was reported in the right common artery.No damage was noted to package.The device was prepared per ifu with no issues noted.No embolic protection was used.The device did not pass through a previously deployed stent.It was reported the device was unable to cross the lesion.The device was removed and a 5x100 evercross balloon was used to complete the procedure.No patient injury was 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: 7435841
• Report Number: 2183870-2018-00234
• Device Sequence Number: 16202658
• Product Code: FGE
• UDI-Device Identifier: 00821684036433
• UDI-Public: 00821684036433
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/17/2018

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: 06/09/2019
• Device Catalogue Number: PXB35-07-37-135
• Device Lot Number: A291879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR