MAUDE Adverse Event Report: CORDIS DE MEXICO SES SMART CONTROL 10X80 80; STENT, ILIAC

Model Number C10080SV

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.  review of lot 17454370 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.  additional information will be submitted within 30 days of receipt.

Event Description

Post deployment of a smart control to the iliac artery, it was reported that once the delivery system was removed from the patient, a foreign material which seemed as a piece of plastic bag was confirmed from its guide wire lumen.The procedure finished successfully.There was no patient injury.The product will be returned for analysis.  the patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.

Manufacturer Narrative

Complaint conclusion: post deployment of a smart control stent to the iliac artery, it was reported that once the delivery system was removed from the patient, a foreign material which seemed to be a piece of plastic bag was confirmed from its guide wire lumen.The procedure finished successfully.There was no patient injury.The device was stored, inspected and prepped per ifu (instructions for use).The patient¿s vessel level of tortuousness and calcification are unknown.The rate of stenosis is unknown.No additional information is available.The product was returned for analysis.One non-sterile smart control 10 x 80 80 cm stent delivery system was returned.Per visual analysis no original packaging was returned.The locking pin had been removed from the unit and was not returned.The unit had been deployed with no stent returned.The inner member had been deployed 5.0 cm at the distal end.A kink was detected on the outer member shaft at 5.5 cm from id band.No other anomaly was noted.The catheter od and id were measured adjacent to the kink on the outer member shaft and were found within specification.A device history record (dhr) review of lot 17454370 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-foreign material - during use¿ was not confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review no foreign material was found in or on the device and the product was found to be within specification.According to the instructions for use ¿do not use if the pouch is opened or damaged.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.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.Flush the flushing valve of the stent delivery system with heparinized saline using a 3 cc syringe to expel air.Continue to flush until saline weeps from the distal catheter end.Flush the guidewire lumen of the stent delivery system with heparinized saline using a 20 cc syringe to expel air.Continue to flush until the saline flows out of the wire lumen at the distal catheter tip.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.¿ the ifu statement is not intended as a mitigation of risk factors.Neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SES SMART CONTROL 10X80 80
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6328483
• MDR Text Key: 67334608
• Report Number: 9616099-2017-00911
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: C10080SV
• Device Catalogue Number: C10080SV
• Device Lot Number: 17454370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/20/2017
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1