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

Catalog Number	PXB35-07-57-080
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Patient Problem/Medical Problem (2688)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a visi-pro balloon expandable stent to treat a lesion with a severe degree of tortuosity and calcification and demonstrating (b)(4) stenosis at the common iliac artery and superficial femoral artery (sfa).The device was prepped per the ifu.No embolic protection was used during the procedure.Resistance was encountered when advancing the device and excessive force used during delivery and withdrawal.It was reported that deployment issues were experienced and the physician was unable to deploy the stent resulting in a delivery failure.The stent dislodged during removal, which required intervention.This dislodged stent was not removed and it remained in place.It was reported that a balloon was passed through the dislodged stent and it was deployed.The physician used another stent to complete the procedure.Patient injury was reported and complications following the incident included vessel damage/injury, perforation, hematoma and hemorrhage/bleed at the access site.Patient experienced retroperitoneal bleeding.A common femoral cut-down procedure was performed.

• 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: 6844191
• Report Number: 2183870-2017-00377
• Device Sequence Number: 1419749
• Product Code: FGE
• UDI-Device Identifier: 00821684036440
• UDI-Public: 00821684036440
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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: 09/06/2019
• Device Catalogue Number: PXB35-07-57-080
• Device Lot Number: A339119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 09/06/2017
• 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
• Patient Age: 84 YR