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

Catalog Number C06060ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint conclusion: the site reported that a 6 x 60mm smart control iliac stent delivery system (sds) failed to cross the lesion.The procedure was successfully completed with a balloon catheter with no reported patient injury.When returned for initial evaluation, the sds was noted to have a frayed catheter tip and a near separation near the strain relief.Attempts to clarify when this damage occurred have not been successful.The event involved a patient with a target lesion in the superficial femoral artery that was described as calcified.The sds was reported to have been prepped according to the instructions for use (ifu).The site reported that the sds failed to cross the target lesion despite multiple attempts.In addition, they reported that they had not noted any damage to the device when it was removed.The procedure was completed with a balloon catheter with no reported patient injury.One non-sterile smart control, iliac 6x60ml was received in a plastic bag.The outer member presented a partial separation at 1cm from the id band and the distal tip was received frayed.No other anomalies were observed.The outer member and the distal tip were observed under a microscope and the damages were confirmed.Sem results showed that the surface of the distal tip revealed evidence of elongation at the areas surrounding the fray.Elongation is a common characteristic of pieces which were stretched/ pulled.Stretching/ pulling could have been related to these characteristic.Sem results show that the partial separation on the external surface of the outer member had evidence of elongation at the areas surrounding 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.The outer diameter of the outer sheath was measured and it was found to be within specification.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿stent delivery system (sds) ¿ failure to cross¿ event was not confirmed since the device passed dimensional testing.The reported ¿catheter tip ¿ frayed/split/torn¿ event was confirmed based on the visual analysis.The cause of the partial separation and the catheter tip frayed condition could not be conclusively determined.However, the analysis of the device revealed evidence of elongation suggestive of pulling and/or stretching.According to the product ifu, this device is indicated for use in common and/or external iliac arteries.The safety and effectiveness of this device has not been demonstrated in patients with lesion that are either totally or densely calcified.The ifu further instructs the user to withdraw the system if resistance is met during the device¿s introduction.Based on the information available for review, there are vessel characteristics (calcified lesion) and procedural factors (repeated attempts to cross the lesion and evidence of elongation) that may have contributed to the reported events.Neither the device history record review not the product analysis suggests that the reported events were related to the manufacturing process.Therefore, no corrective actions will be taken.

Event Description

During a stenting procedure to the superficial femoral artery, it was reported that the smart control stent delivery system (sds) failed to cross the lesion.The procedure was completed by using a balloon and there was no patient injury reported.The device was prepped per ifu.There were no other anomalies present once removed from the patient.The lesion was calcified.The product will be returned for analysis.Per the preliminary visual analysis of the device, there is a near separation at 1cm from strain.Per the sales representative, she was not present during the case.The account only said that the stent did not cross the lesion.Per the physician, the lesion was very difficult and they attempted several times with the device.The sales representative reported that the device was given to her in a bio-hazard bag since there was blood on the handle so she was not able to tell if there was any separation.Per failure analysis lab (fal), the distal end presented a frayed condition.

• 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: 5078072
• MDR Text Key: 25831519
• Report Number: 9616099-2015-00431
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: C06060ML
• Device Lot Number: 17118853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN BALLOON