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

Catalog Number C07100ML

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

As reported, the smart stent delivery system had strong resistance with the non-cordis guidewire and locked with it.The guidewire and stent were removed from the patient and another stent and guidewire was used.There was no reported patient injury.After the product was received for decontamination, it was reported that there was "near separation at 1cm from strain (cracked).Stent was detached and not included."the patient was male, but his age was unknown.The intended procedure was a pta.The target lesion was right superficial femoral artery.The lesion was heavily calcified and moderately tortuous.The rate of stenosis was 100%.An approach was made with a non-cordis sheath introducer.After the lesion was crossed with a non-cordis guidewire, a smart control was advanced over the guidewire, however there was strong resistance felt and locked with the guidewire.Therefore the stent and the guidewire were removed from the patient as a unit.Another new stent and a guidewire were used instead.The procedure finished successfully.There was no reported patient injury.The product was clinically used, and it will be returned for analysis.

Manufacturer Narrative

According to the decontamination site, "near separation at 1cm from strain.Stent detached and not included." the device has been received, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.Concomitant devices: radifocus stiff guidewire, terumo; and 6f 45cm destination sheath, terumo.(b)(4).

Manufacturer Narrative

Complaint conclusion: a site reported that during an interventional procedure, the smart control stent delivery system (sds) got locked up on the guidewire.The sds and guidewire were successfully removed together with no reported patient injury.When the device was returned, the device was noted to have a ¿near separation¿ near the strain relief.The event involved a (b)(6) male with a heavily calcified, moderately tortuous and 100% occluded lesion in his right superficial femoral artery (sfa).Access was obtained with a non-cordis sheath introducer and a guidewire advanced to the lesion.This was followed by the loading of a 7 x 100mm smart control sds on a non-cordis guidewire.During the advancement of the sds, resistance was experienced and the sds locked up on the guidewire.The sds and guidewire were successfully removed together with no reported patient injury.The procedure was successfully completed with another guidewire and sds.When the sds was initially returned, the device was noted to have a ¿near separation¿ near the strain relief.Attempts to clarify whether this ¿near separation¿ occurred prior to shipping have been unsuccessful.One non-sterile smart control, iliac 7x100ml was received coiled inside a plastic bag.Unit was received deployed.Locking pin and id band were not received.The outer member presented a separation at 1cm from outer member hub.No other discrepancies were found.A guidewire 0.035¿ (lab sample) was introduced through the unit and no resistance/friction was felt.The unit was sent to sem analysis in order to analyze the potential cause of separation; sem results show that the outer and inner member surface presented evidence of elongation at the surroundings areas of the separation.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these separation characteristics.Review of lot 16056878 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failure " sds ¿ cracked / separated" reported by the customer was confirmed due to the condition that was received the unit.The exact cause of the separation does not appear to be manufacturing related since during microscopic analysis there is evidence of elongations.The failure reported ¿inner shaft - resistance/friction¿ by the customer was not confirmed since no anomalies were found during functional analysis.The cause of the failure could not be conclusively determined.Therefore no actions were taken.The product instructions for use (ifu) warn that the safety and effectiveness of the smart control iliac stents has not been demonstrated in patients with lesions that are either totally or densely calcified.The ifu further instructs that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Based on the information available for review, there are vessel characteristics (heavily calcified, moderately tortuous and 100% stenosed) that may have contributed to the reported resistance between the sds and the guidewire; while procedural factors (attempts to remove the locked up sds) may have contributed to the observed device separation.The reported ¿inner shaft ¿ resistance/friction¿ was not confirmed since the device passed functional testing.The observed ¿sds ¿ cracked¿ was confirmed by visual and microscopic analysis which revealed evidence of inner and outer member elongation near the separation that are consistent with stretching and pulling of the device.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process.Therefore, no corrective actions will be taken.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• 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: 4352719
• MDR Text Key: 5205249
• Report Number: 9616099-2014-00823
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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: 12/31/2015
• Device Catalogue Number: C07100ML
• Device Lot Number: 16056878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR