MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C06080MV

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that after successfully deploying a smart control 6 x 100 stent in the superficial femoral artery (sfa) target lesion, the physician could not advance an additional 120 cm.Smart control 6 x 80 stent delivery system through the previously deployed stent.The lesion was dilated again with a balloon catheter but the same problem occurred.The device was successfully removed from the patient and another stent was used to complete the procedure successfully.There was no reported patient injury.Visual inspection of the device indicated the tip of the stent was not smooth.Additional information indicated that there was no problem reported deploying the initially deployed smart control stent.The approach for the procedure was contralateral.The target lesion was the superficial femoral artery (sfa).The lesion was reported to be moderately calcified.The product was stored properly according to the ifu.There was no damage noted to the product packaging upon inspection prior to opening.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the instructions for use (ifu) with no problems noted.No additional information is available.Addendum: preliminary inspection of the returned product indicated the distal tip was frayed.

Manufacturer Narrative

The product was returned for inspection.Complaint conclusion: the report received from the affiliate indicated that after successfully deploying a smart control 6 x 100 stent in the superficial femoral artery (sfa) target lesion, the physician could not advance an additional 120 cm.Smart control 6 x 80 stent delivery system through the previously deployed stent.The lesion was dilated again with a balloon catheter but the same problem occurred.The device was successfully removed from the patient and another stent was used to complete the procedure successfully.Visual inspection of the device indicated the tip of the stent was not smooth.The approach for the procedure was contralateral and there was no problem reported deploying the initial stent.The target lesion was a moderately calcified superficial femoral artery.The product was inspected prior to use and appeared to be normal.No additional information is available.There was no reported patient injury.The product was returned for inspection.One non-sterile pkg assy 6x080 smart vas120cm was received coiled inside in plastic bag.Unit was not deployed.Locking pin was in place.Catheter tip (brite tip) was received frayed.One kink was detected on the outer member at.5cm from id band.No other damages could be observed.The outer diameter (od) of the outer sheath was measured in different distances and found within specification.The unit was sent to sem analysis in order to analyze the potential cause of catheter tip damaged (brite tip); sem results showed that the brite tip surface presented evidence of elongation at the surrounding areas of the frayed.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these characteristic.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.The cause of the "kink" condition found could not be conclusively determined; however it does not appear to be manufacturing related.Controls are in placed at the final assembly and packaging processes to detect this kind of issue (kink).The failure reported ¿catheter tip - smart/flexstent/smart control/precise - damaged¿ by the customer was confirmed; the cause of the failure was not conclusively determined.The failure does not appear to be manufacturing related.Neither the dhr review nor the analysis suggests that the failure is manufacturing process.During manufacturing process there are controls to detect this kind of issue.Therefore no actions were taken.The failure "sds - tracking difficulty-through another stent" reported by the customer was not confirmed since outer diameter was found within specification.The cause of the failure could not be conclusively determined.Neither the dhr review nor the analysis suggests that the failure is manufacturing related.Therefore no actions were taken.With the information available it appears that vessel characteristics and procedural factors may have contributed to the reported events.Please note that this is the initial/final report for this file.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4105339
• MDR Text Key: 4703135
• Report Number: 9616099-2014-00609
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/14/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: C06080MV
• Device Lot Number: 16006876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 09/22/2014
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: SMART CONTROL 6 X 100 STENT