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

Catalog Number	PXB35-07-17-080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Patient Problem/Medical Problem (2688)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician treated a 15mm moderately calcified lesion in the proximal celiac artery with a visi-pro balloon- expandable stent.The artery had a diameter of 7mm and had little tortouosity.The visipro was prepped as per the ifu with no issues identified.The procedure used a 7 fr sheath and a non-medtronic wire.014" x 300 cm.No resistance was encountered advancing the device and no excessive force was used.Two weeks after the procedure, patient complained of pain and a follow cannulation of the artery was performed.During this follow-up visit, it was noticed that the implanted stent had fractured.The component embolized in the vessel.The broken part of the device was explanted using a snare.The physician opted for no further treatment.The patient complained of abdominal pain and was referred to a gi physician.No further complications reported.
Additional Manufacturer Narrative
Evaluation summary: a small fractured segment of the visi-pro balloon-expandable biliary stent crimped onto a guidewire was received for evaluation.No cine images were received.Approximately 8mm of the stent was returned crimped onto a guidewire.Sanguine residue and biological debris was noted in the stent strut cells.The returned stent structure exhibited stent cell elongation and lateral compression.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: 7269135
• Report Number: 2183870-2018-00087
• Device Sequence Number: 13888649
• Product Code: FGE
• UDI-Device Identifier: 00821684036389
• UDI-Public: 00821684036389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 11/28/2020
• Device Catalogue Number: PXB35-07-17-080
• Device Lot Number: A562005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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