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

Catalog Number C07040MV

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2013

Event Type  malfunction  

Manufacturer Narrative

This is the initial and final report for this event.(b)(4).(b)(6).Complaint conclusion: a report was received that the distal tip of a smart control stent delivery system (sds) was noted to be kinked when it was removed from its¿ packaging.The procedure was completed with another device with no reported patient injury.Initial evaluation of the device revealed that the brite tip of the outer member was frayed or split.The site reported that the 7 x 40mm 120cm smart control vascular device had been stored and handled according to the instructions for use (ifu).No damage had been noted on the device packaging prior to it being opened.No difficulty was experienced while removing the device from the package.When the packaging was opened, the site noted that the distal tip of the sds was kinked.The device was exchanged and the procedure completed with no reported patient injury.Initial evaluation of the device revealed that the brite tip of the outer member was frayed or split.The site reported that they had not noted this damage prior to shipping the device and explained that it might have occurred during the shipment of the device back to the manufacturer.No further information is available.A non-sterile unit of pkg assy 7x040 smart vas120cm was received inside of a plastic bag.Smart catheter was received with the locking pin in the handle.A kink was observed 117cm from the distal along with a compressed condition on the tip of the smart catheter body.The catheter was inspected under the vision system and the distal brite tip of the outer member was observed to be frayed/split.The stent positioned in the clear section and outside of the outer member.Sem analysis revealed evidence of elongations and stress lines at the areas surrounding the frayed/split condition on the brite tip.Elongations and stress lines can suggest an application of stress that exceeds the material yield strength and are common characteristics of pieces which were stretched/ pulled until separation.No other issues were found during sem analysis.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿catheter tip- smart/flexstent/smart control/precise- kinked/bent¿ event was confirmed during the visual analysis.In addition, the distal tip was found to be compressed and the outer member brite tip was noted to have a frayed/split condition.The cause of the events could not be conclusively determined during analysis; though the evidence provided by the analysis suggests that procedural factors may have contributed to it.Based on the information provided, there are shipping and handling factors (site report that they had not noted the brite tip condition and evidence of elongation) that may contributed to these events.Neither the device history record review nor the product analysis suggests that the reported events were related to the manufacturing process.Therefore, no corrective actions will be taken.

Event Description

Before use on the patient, it was reported that the physician found the tip of the 7x040 120cm smart to be kinked.It was noted after removing the product from the packaging.There was no report of patient injury as the device was not used in the patient.The procedure was completed successfully.The device will be returned for analysis.The intended target lesion was located in the superficial femoral artery (sfa).The product was stored and handled according to the ifu.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the package.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.Analysis of the returned product revealed that the brite tip (distal tip) of outer member was observed to be frayed/split.A sem analysis was required to determine the cause of the brite tip flayed/split and the results showed that evidence of elongations and stress lines at the surrounding areas of the frayed/split condition found on the brite tip.According to the affiliate, the condition was not noted prior to shipment for inspection.However, it cannot be identified at this moment if unusual force was applied during the product return process.No further information is available.

Manufacturer Narrative

Additional information was provided by the affiliate that the event occurred in (b)(6) 2013, not on (b)(6) 2015, as originally reported.Please refer for the correct event date.Please note that the event date ((b)(6) 2013) was provided incorrectly in order to meet electronic medwatch acceptance requirements.It is only know that the event occurred in (b)(6) 2013; the exact day is currently unknown.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5064742
• MDR Text Key: 25344311
• Report Number: 9616099-2015-00417
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 07/14/2015

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: 06/30/2014
• Device Catalogue Number: C07040MV
• Device Lot Number: 15653942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1