MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PRB35-06-060-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: visual inspection: the protégé was received with the locking pin tightened.The deployment grips were approximately 8cm apart from each other.The distal end showed the stent was approximately 5mm exposed from the outer assembly.No damage was observed to the distal tip, outer assembly, exposed inner assembly, or the stent.The stent showed no signs of fracture; the tantalum markers were all visible.The distal tip of the catheter was inspected and was oval-shaped.Functional testing: a 0.035 guidewire from the lab was attempted to be front-loaded, however resistance was encountered approximately 35cm from the distal tip.The same guidewire was attempted to be back-loaded, however resistance was encountered again.The catheter was flushed with water and the guidewire was wetted.Resistance was encountered between 20cm to 85cm from the distal tip multiple segments throughout the catheter.Also when resistance was encountered while withdrawing the guidewire, the stent would deploy further due to the subjected tensile forces.The stent was deployed by unlocking the pin and pulling the distal deployment grip.No damage to the stent was observed.The catheter was cut in order to view the inner assembly.Found no traces of debris within the tubing.Deformation of the inner assembly was noted at multiple segments between 20cm and 85cm.
Event or Problem Description
Physician was attempting to implant a protégé everflex stent in a lesion in the sfa.The device was prepped with no issues identified.The stent was loaded on the 0.035 guidewire.It was reported that when physician was advancing the stent catheter, he encountered ¿slight¿ resistance as the catheter moved forward.As the catheter tip approached the hub of sheath, the stent was noticed to be partially deployed.The procedure was completed with another stent.No injury to patient was reported.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6376556
• Report Number: 2183870-2017-00102
• Device Sequence Number: 650128
• Product Code: FGE
• UDI-Device Identifier: 00821684069189
• UDI-Public: 00821684069189
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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: 12/21/2018
• Device Model Number: PRB35-06-060-120
• Device Catalogue Number: PRB35-06-060-120
• Device Lot Number: A205152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1