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

Catalog Number	PXB35-07-27-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image evaluation: the visi-pro balloon-expandable biliary stent system was not received for evaluation.A single cine image post procedure was provided for review.The cine image is of the implanted visi-pro balloon expandable stent.This image shows the stent being elongated and one of the stent radiopaque markers can be seen to be out of the plane of the other three markers.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Patient previously had a visi pro stent implanted to treat a severely calcified lesion in the proximal left common iliac artery.The procedure was completed without issue.It is reported that a fluoroscopy image shows that the stent was observed to be fractured/damaged.Component embolized in the vessel.No procedure carried out, but patient referred for a cta and follow up doctor¿s office visit.The patient is stable with no issues.

• 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: 7424471
• Report Number: 2183870-2018-00226
• Device Sequence Number: 16407163
• Product Code: FGE
• UDI-Device Identifier: 00821684036419
• UDI-Public: 00821684036419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/12/2018

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: 06/29/2019
• Device Catalogue Number: PXB35-07-27-135
• Device Lot Number: A302661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 74