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

Catalog Number	PXB35-07-37-080
Medical Device Problem Codes	Premature Activation (1484); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cine image review: the visi-pro balloon-expandable biliary stent system was not received for evaluation.Two photographic images of cine images were provided.The two images were examined.The visi-pro balloon does not appear to be inflated.A support catheter could not be seen.The visi-pro stent marker hoops appear to have slid off their t=0 position over the radiopaque marker band of the balloon.Based on the guidewire path in the images the dislodgement of the stent happened after the visi-pro navigated through a tight curve in the vessel anatomy.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using one visipro device to treat a slightly tortuous fibrous lesion, located in the mid right femoral / femoral bypass area, exhibiting 75% stenosis.Embolic protection was not used.The device was removed from its packaging and prepped per the ifu with no issues noted.The lesion was not predilated.The device did not pass through a previously deployed stent, resistance was not encountered when advancing the device and excessive force was not used.It was reported that while the physician was advancing the device to the lesion site, the stent deployed at an unintended site.The physician used a longer sheath and deployed a second stent in the original appropriate position.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: both sheaths used in the procedure were non-medtronic sheaths.The first stent partially deployed at the unintended lesion and was fully deployed by the physician by inflating the balloon.The unintended lesion was proximal to the intended lesion.The second stent, that was deployed in the intended lesion, was another visipro stent.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: 7365581
• Report Number: 2183870-2018-00180
• Device Sequence Number: 1963621
• Product Code: FGE
• UDI-Device Identifier: 00821684036426
• UDI-Public: 00821684036426
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 01/25/2021
• Device Catalogue Number: PXB35-07-37-080
• Device Lot Number: A587385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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