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

Model Number C06080ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  malfunction  

Manufacturer Narrative

A physician is reported to have encountered resistance during the advancement of a 6 x 80mm smart control stent delivery system (sds).The device was successfully removed with no reported patient injury.Once removed, the distal tip of the sds was noted to be frayed.The event involved a patient who was undergoing stent implantation of a 99% stenosed, heavily calcified and mildly tortuous left superficial femoral artery lesion.The target lesion was pre-dilated prior to the use of the smart control sds.The site did not note any damage to the smart control packaging when it was inspected prior to opening.No difficulty was experienced while opening the package and the product appeared normal prior to use.The device was prepped according to the instructions for use (ifu).The device was advanced via an antegrade approach but resistance was encountered while attempting to cross the lesion.The sds was removed without issue and additional pre-dilation was conducted with a balloon.When the physician attempted to re-insert the sds, the distal tip was noted to be frayed.The device was exchange for another smart control sds and the procedure successfully completed with no reported patient injury.The product was not returned for analysis.A device history record (dhr) review was performed and revealed that this lot of products met all requirements per the applicable manufacturing quality plan.The product ifu warns that the safety and effectiveness of the device has not been demonstrated in patients with lesions that are either totally or densely calcified.It further instructs that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, can cause the outer member to compress, thus contributing to premature stent deployment/stent jumping while the locking pin is still in.Based on the information available for review, there are vessel characteristics (99% stenosed, heavily calcified and mildly tortuous) and procedural factors (use of device after resistance encountered) that may have contributed to the reported event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the dhr, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective actions will be taken at this time.

Event Description

As reported, after pre-dilation the physician encountered resistance during advancement of a smart control 6 x 80 stent delivery system.The product was successfully removed and additional pre-dilation was conducted.The physician then attempted to re-insert the smart control device but noted that the distal tip was frayed.Therefore, the physician stopped using and exchanged it for another new smart control.The procedure was finished successfully.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was the left superficial femoral artery.The lesion was reported to be: a 99% stenosis, heavily calcified, and mildly tortuous.Additional information has been requested.

Manufacturer Narrative

Additional information received indicated that: 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 other product issue was noted upon inspection of the product after removal from the patient or prior to shipping.The approach for the procedure was antegrade.No additional information is available.(b)(6).Contact info is unknown.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

(b)(6).The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

• 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: 4277291
• MDR Text Key: 12646934
• Report Number: 9616099-2014-00767
• 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,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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 Model Number: C06080ML
• Device Catalogue Number: C06080ML
• Device Lot Number: 16044433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1