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

Catalog Number	PXB35-08-27-135
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 was attempting to use a visi pro balloon expandable stent to treat a lesion in the subclavian artery.The device was prepped as per the ifu with no issues identified.The lesion was not pre-dilated and no embolic protection was used.There was no resistance encountered advancing the device and it did not pass through a previously deployed stent.The balloon expandable stent dislodged upon attempts to deploy it in the subclavian.It was retrieved but was not able to be withdrawn through the sheath so they deployed the stent in the common iliac.Another stent was used to treat the subclavian.
Additional Manufacturer Narrative
A non-mdt balloon expandable stent was used to complete the procedure.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: 7731489
• Report Number: 2183870-2018-00401
• Device Sequence Number: 13850049
• Product Code: FGE
• UDI-Device Identifier: 00821684036495
• UDI-Public: 00821684036495
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 07/07/2019
• Device Catalogue Number: PXB35-08-27-135
• Device Lot Number: A306789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/28/2018; 10/03/2018
• 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
• Patient Age: 71 YR