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

Catalog Number C08040SL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices: guidewire (chevalier 14 tapered 3, chevalier 14 tapered 15) angiographic catheter (tempo, cordis), micro catheter (prominent, tokai medical), balloon catheter (2*20 bandicoot, kaneka) and balloon catheter (saber, cordis).Complaint conclusion: difficulty was experienced when attempting to cross a lesion with an 8 x 40mm smart control iliac stent delivery system (sds).The device was removed and the lesion re-dilated.When attempting to re-insert the smart sds, the site noted that the distal tip was frayed and kinked and it was removed.The procedure was successfully completed with another device with no reported patient injury.The event involved a patient undergoing endovascular intervention of a target lesion in the left common iliac artery that was described as 100% stenosed, heavily calcified and mildly tortuous.The patient¿s vasculature was accessed via an ipsilateral approach and the lesion pre-dilated.The sds was inspected prior to use and no damages were noted and the product was prepared according to the instructions for use (ifu).Resistance was encountered when trying to cross the target lesion with the sds.The physician attempted to advance the sds by force but it was still difficult to advance.The device was removed from the patient and the target lesion re-dilated.When the site attempted to re-introduce the smart control sds, they noted that the distal tip was frayed and had gotten kinked.The sds was exchanged for another device and the procedure completed with no reported patient injury.The device was not returned to the manufacturer for evaluation.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Without the return of the device for analysis, the reported event could not be confirmed and no determination of possible contributing factors could be made.According to the ifu, the safety and effectiveness of this device has not been demonstrated in patients with lesions that are either totally or densely calcified.The ifu further details that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Based on the information provided for review, there are vessel characteristics (heavy calcification) and procedural factors (pushing against resistance) that may have contributed to these events.Neither the device history record review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

Event Description

During a stenting procedure to the left common iliac artery, it was reported that a smart control stent was attempted to place to the lesion, however, there was resistance felt.The physician tried to advance the stent by force but it was difficult to advance it.An additional-dilation was conducted with a saber balloon catheter.The smart control was attempted to reinsert but it was found that the distal tip was frayed and got kinked.Therefore, it was changed to another new stent.The procedure finished successfully.There was no reported patient injury.The device was prepared as specified by the instructions for use.There was no apparent damage to the device noticed prior to use.An ipsilateral approach was made from the left femoral artery.A guidewire (chevalier 14 tapered 3, chevalier 14 tapered 15) crossed the lesion under an angiographic catheter (tempo, cordis) and a micro catheter (prominent, tokai medical).Pre-dilation was conducted with a balloon catheter (2x20 bandicoot, kaneka).It is unknown if the device passed through any acute bends.The lesion was heavily calcified and mildly tortuous.The rate of stenosis was 100%.The product will not be returned for analysis.

• 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: 5172630
• MDR Text Key: 29216093
• Report Number: 9616099-2015-00511
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: C08040SL
• Device Lot Number: 17167205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1