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

Catalog Number	PMB4-6-14-80
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/10/2019
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 the physician intended was using a paramount mint stent to treat a slightly calcified, slightly tortuous, 95% stenotic lesion in the proximal renal artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.A 6fr non-medtronic sheath and a 0.014 non-medtronic guidewire were used for the procedure with no embolic protection.The lesion was pre-dilated with a 3mm a 5mm device.The device did not pass through a previously deployed stent however, resistance was encountered and excessive force applied during delivery of the device to the lesion.It was reported that the stent dislodged.A snare was used to capture the dislodged stent.Another stent was used to complete the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the stent dislodged just before the target lesion.Stent was snared outside the guide catheter.No injury to the patient.A non-medtronic stent was used to complete procedure.The patient is doing well.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation visual inspection.The snare loaded inside the 6f sheath assembly showed a stent captured by the distal end of the snare device.The stent was intact and showed no signs of expansion.Damage noted to the sent was observed where the snare hoop captured the stent.The deployment system for the paramount mini was returned.The balloon showed no indication of a prior inflation.The shape of the stent struts were note on the exterior of the balloon.No damage to the deployment system was noted.Cine image review cine images from the reported procedure have been provided.The first image analyzed showed the target area prior to treatment.No device was visible within the vessel.The second cine image analyzed showed the stent dislodged from the balloon segment of the deployment system being captured by a snare device.The stent showed no signs of expansion.The proximal end of the sent was flared upwards at the area of where the suspected snare device captured the stent.The third image showed a suspected second paramount mini inside the vessel with the balloon expanded and the stent deployed.The fourth image analyzed shows the improved blood flow of the treated 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: 8694954
• Report Number: 2183870-2019-00333
• Device Sequence Number: 19401826
• Product Code: FGE
• UDI-Device Identifier: 00821684006399
• UDI-Public: 00821684006399
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2019

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: 12/17/2020
• Device Catalogue Number: PMB4-6-14-80
• Device Lot Number: A572295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 08/27/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/24/2019; 08/29/2019
• 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
• Patient Age: 84 YR
• Patient Weight: 56