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

Catalog Number	PMB8-5-18-80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the paramount mini was returned for evaluation.The paramount mini was inspected and verified the stent was still loaded.Dried blood was noted in the manifold and around the stent/balloon segment of the catheter.It was noted at the proximal end of the stent, one of the radiopaque hoops was bent distally.The shape of the stent showed signs of compression/buckling.A 0.018" lab guidewire was front loaded and the od of the stent was measured (distal 0.0715", proximal 0.092").If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting use a paramount mini gps balloon-expandable stent to treat a 15mm plaque lesion with little calcification in the right proximal renal artery exhibiting 90-95% stenosis.The artery was 5 mm in diameter, and was extremely tortuous.The artery was reported to have a very significant angle of origin off the aorta.The procedure used a 6 fr non-medtronic sheath and a 0.018" non-medtronic guidewire.The vessel was pre-dilated using a non-medtronic 3x20 device at 8atms for 45 sec which was then increased to 12 atms and balloon ruptured but was removed intact.The physician then attempted to use a 5x18 paramount mini balloon-expandable stent which failed to cross the lesion.There was difficulty removing the paramount mini stent.The vessel was then pre-dilated for a second time with a mdt 4x40 plus at 8 atms for 60 seconds.The physician exchanged the wires to non-medtronic 0.014".The physician then attempted to use another paramount mini balloon-expandable 5x14 stent, which also failed to cross the lesion.The procedure was successfully completed using a 5x40 non-medtronic pta balloon inflated to 8 atms for 60 seconds.No patient injury was rep orted.

• 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: 7077308
• Report Number: 2183870-2017-00538
• Device Sequence Number: 1144995
• Product Code: FGE
• UDI-Device Identifier: 00821684006597
• UDI-Public: 00821684006597
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/01/2017

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: 10/28/2019
• Device Catalogue Number: PMB8-5-18-80
• Device Lot Number: A367238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 71