MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X60; STENT, ILIAC

Model Number	C08060SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there was an attempted to deploy a smart control stent in the target lesion.However the distal end of the stent was confirmed to be prematurely deployed.The smart control was replaced with a new unknown stent and the procedure was completed successfully.There was no reported patient injury.The target lesion was the common iliac artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The temperature was exposure indicator on the pouch checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was inspected, prepped, stored and handled according to the instructions for use (ifu) with nothing unusual or damages noted about the stent delivery system prior to use.The product was clinically used and will not be returned for analysis.No other information was provided.The product was not returned for analysis.A device history record (dhr) review of lot 17629935 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)- deployment difficulty-premature/in patient¿ could not be confirmed as the device was not returned for analysis and films were not available for review.The exact cause could not be determined.Vessel characteristics although unknown may have contributed to the reported event.It is unknown if unusual force was used in the attempt to cross the lesion as pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, can cause the outer member to compress, thus contributing to premature stent deployment.According to the instructions for use, the cordis s.M.A.R.T.Control nitinol stent system is designed to deliver a self-expanding stent to the iliac arteries.The ifu states ¿do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Introduction of stent delivery system: ensure locking pin is still in place.Advance the device over the guidewire through the hemostatic valve and sheath introducer.¿safety and effectiveness has not been demonstrated in lesions that are either totally or densely calcified.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Set the backer board with carrier tube on a flat surface.Remove the stent/delivery system from the carrier tube.Examine the device for damage.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.
Event or Problem Description
It was reported that there was an attempted to deploy a smart control stent in the target lesion.However the distal end of the stent was confirmed to be prematurely deployed.The smart control was replaced with a new unknown stent and the procedure was completed successfully.There was no reported patient injury.The target lesion was the common iliac artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The temperature was exposure indicator on the pouch checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was inspected, prepped, stored and handled according to the instructions for use (ifu) with nothing unusual or damages noted about the stent delivery system prior to use.The product was clinically used and will not be returned for analysis.No other information was provided.

• Brand Name: SMART CONTROL, ILIAC 8X60
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6856167
• Report Number: 9616099-2017-01420
• Device Sequence Number: 16267489
• Product Code: NIO
• UDI-Device Identifier: 20705032024157
• UDI-Public: 20705032024157
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 12/31/2018
• Device Model Number: C08060SL
• Device Catalogue Number: C08060SL
• Device Lot Number: 17629935
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1