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

Catalog Number	PMB4-5-18-80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use a paramount mini gps balloon-expandable stent with a 6fr non-medtronic sheath and a non-medtronic guidewire to treat a moderately calcified plaque lesion in the proximal inferior mesenteric artery (95%).Artery diameter reported as 4mm and lesion length reported as 20mm.The vessel was moderately tortuous.The device was prepped as per the ifu with no issues identified.The vessel was pre-dilated using a 3x40 nanocross pta balloon.Resistance was encountered advancing the device, no excessive force was used and the device did not pass through a previously deployed stent.It was reported that stent deformation occurred in vivo during positioning.The deformed stent was removed without any difficulty and a new stent was used to complete the procedure.No stent elongation or shortening was noted.No patient injury was reported.

• 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: 7262120
• Report Number: 2183870-2018-00074
• Device Sequence Number: 1223472
• Product Code: FGE
• UDI-Device Identifier: 00821684006412
• UDI-Public: 00821684006412
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 12/19/2019
• Device Catalogue Number: PMB4-5-18-80
• Device Lot Number: A391623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR