MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X30; STENT, ILIAC

Model Number	C08030SL
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Frayed (1262); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the procedure, a non-cordis guidewire crossed the lesion and a sleek balloon catheter was inflated.A  smart control stent was delivered to the lesion but the stent was unable to be deployed.The guidewire in use was exchanged for another non-cordis guidewire and the stent was attempted to be deployed once more.However, the smart control stent got stuck with the guidewire and both devices were removed.After the removal, it was confirmed that the distal tip of the smart control was frayed.The stent was replaced with a new one and the procedure was finished successfully.There was no reported patient injury.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.The patient¿s information was unknown.An approach was made from the right femoral artery.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.Additional procedural details were requested but are unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17439361 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)-ses deployment difficulty - unable¿ and ¿catheter tip frayed/split/torn¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Due to the limited information it is difficult to determine whether procedural factors may have contributed to the reported event.According to the instructions for use ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
It was reported that during the procedure, a non-cordis guidewire crossed the lesion and a sleek balloon catheter was inflated.A  smart control stent was delivered to the lesion but the stent was unable to be deployed.The guidewire in use was exchanged to another non-cordis guidewire and the stent was attempted to be deployed once more.However, the smart control stent got stuck with the guidewire and both devices were removed.After the removal, it was confirmed that the distal tip of the smart control was frayed.The stent was replaced with a new one and the procedure was finished successfully.There was no reported patient injury.The patient¿s information was unknown.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.An approach was made from the right femoral artery.The product was clinically used and it will not be returned for analysis.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 8X30
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6287375
• Report Number: 9616099-2017-00883
• Device Sequence Number: 16327992
• Product Code: NIO
• UDI-Device Identifier: 20705032024072
• UDI-Public: 20705032024072
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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: 02/28/2018
• Device Model Number: C08030SL
• Device Catalogue Number: C08030SL
• Device Lot Number: 17439361
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SLEEK BALLOON CATHETER