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 Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cines and operative reports analysis summary: the paramount mini balloon-expandable biliary stent system was not received for evaluation.No ancillary devices from the procedure were received.Three cine images were received with the initial reported event.Three operative reports were received in later correspondence.The first cine image is of the renal artery implanted stent.The stent exhibits a fracture and 90% ostial stenosis.The second and third cine images are of the embolized stent fragment in the patient¿s right superficial femoral artery.
Event or Problem Description
On the (b)(6) 2014, a patient underwent treatment for left renal artery calcified stenosis of 90% at the ostium of the vessel using a 5x18 mm paramount mini stent and angioplasty.The procedure used a 5 fr sheath and a 0.014¿ guidewire.The stent was first deployed to 6 and then to 7 atm.The procedure was successful.During a follow up for the procedure on the (b)(6) 2017, the patient was experiencing pain in the right lower extremity.An aortogram was performed and it was found a portion of the paramount stent was in the mid-distal right sfa.The fractured stent was not causing vascular compromise.The physician opted to perform angioplasty of the renal stent portion to secure it.Revascularization of the right femoral popliteal segment was also performed with atherectomy procedure.On the (b)(6) 2017, the left renal artery fractured stent was covered using a 4 mm and 5 mm balloon and then deploying a non-medtronic stent graft to 12 atm.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: 7123689
• Report Number: 2183870-2017-00588
• Device Sequence Number: 1423192
• Product Code: FGE
• UDI-Device Identifier: 00821684006412
• UDI-Public: 00821684006412
• 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): 12/15/2017

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: 05/05/2017
• Device Catalogue Number: PMB4-5-18-80
• Device Lot Number: A006422
• 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: 81 YR