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

Catalog Number	PMB4-6-21-80
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was attempting to use a paramount mini balloon-expandable stent to treat a 14mm severely calcified lesion in the right proximal renal artery.The artery was 6 mm in diameter, moderately tortuous and had 80% stenosis.The procedure used a 6 fr non-medtronic sheath and a non-medtronic 0.024" guidewire.The device was prepped as per the ifu with no issues identified.The vessel was pre-dilated using a 3x20 pre-dilation device.The physician encountered resistance advancing the paramount mini, no excessive force was used.The stent would not cross the lesion.Stent dislodgement occurred during removal following failed delivery and the stent was removed using a gooseneck snare.The case was aborted and will be rescheduled for an attempt to reach the lesion through arm access.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: 7123450
• Report Number: 2183870-2017-00584
• Device Sequence Number: 13902841
• Product Code: FGE
• UDI-Device Identifier: 00821684006450
• UDI-Public: 00821684006450
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/15/2017

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: 03/31/2019
• Device Catalogue Number: PMB4-6-21-80
• Device Lot Number: A253286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 75 YR
• Patient Weight: 103