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

Catalog Number	PXB35-07-57-135
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Occlusion (1984); Patient Problem/Medical Problem (2688)
Date of Event	02/27/2019
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 a visipro 035 stent to treat a lesion in the iliac.The lesion was not pre-dilated.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.A 5/6fr non-medtronic short sheath and a non-medtronic 0.035 guidewire were used for the procedure.No embolic protection was used.The device did not pass through a previously deployed stent.Resistance was not encountered nor was excessive force applied during attempted delivery of the device to the lesion.It was reported that the stent deployed in the posterior tibial artery.The physician finished the case by stenting the illac with a 7 x 60 protégé se stent.The physician also treated the sfa using a hawkone, followed by 2, 6 x 150 protégé stents followed by post dilation using a 6 x 100 device.It was reported that the patient¿s posterior tibial was occluded.
Additional Manufacturer Narrative
Additional information: occlusion of the patient¿s posterior tibial is reported to be due to the stent dislodgement and the vessel remains occluded.The physician does not plan to intervene again at this time.All other devices used in this procedure functioned as intended.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.

• 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: 8390381
• Report Number: 2183870-2019-00115
• Device Sequence Number: 1471458
• Product Code: FGE
• UDI-Device Identifier: 00643169787827
• UDI-Public: 00643169787827
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 10/30/2021
• Device Catalogue Number: PXB35-07-57-135
• Device Lot Number: A732444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/05/2019; 06/19/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/20/2019; 06/20/2019
• 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