MAUDE Adverse Event Report: COVIDIEN PARAMOUNT MINI GPS BALLOON-EXPANDABLE BILIARY STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PMB8-6-14-80
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/13/2019
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 a physician was attempting to use paramount mini stent to treat a right distal lesion in the iliac artery - common of a patient in a procedure.No damage noted to packaging noted, no issues noted when removing the devices from the hoop/tray, devices was prepped as per ifu.It was reported that one of the stent¿s dislodgement occurred during delivery to/at lesion, it just came loose.The dislodged sent was removed using a snare.The second stent dislodged but was and fully expanded in the external iliac artery.The devices did not pass through a previously-deployed stent, resistance was not encountered when advancing the devices, excessive force was not used.No further patient injury reported for this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the second stent dislodged while trying to get into the renal artery and attempts were made to remove it however, because it had become loose, it was fully expanded in the external iliac artery which was not the intended area.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PARAMOUNT MINI GPS BALLOON-EXPANDABLE BILIARY STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8389451
• Report Number: 2183870-2019-00114
• Device Sequence Number: 1471405
• Product Code: FGE
• UDI-Device Identifier: 00821684006573
• UDI-Public: 00821684006573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2019

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: 05/16/2019
• Device Catalogue Number: PMB8-6-14-80
• Device Lot Number: A278238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 05/30/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/26/2019; 05/31/2019
• 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