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

Catalog Number C08040SL

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2014

Event Type  Injury  

Event Description

The report received from the affiliate indicated that during pta of a lesion in the superficial femoral artery an 8x30mm smart control stent got stuck in an 8x40mm smart control stent implanted previously which moved distally.The 8x30 stent was removed and an 8x80mm was deployed to cover the lesion.Preliminary evaluation of the 8x30 stent showed that the stent was protruding.The lesion had heavy calcification and moderate tortuosity.The rate of stenosis was 100 %.A contralateral approach was made from the right femoral artery.After the lesion was pre-dilated, two smart controls (8/150mm, 8/40mm) were implanted.However the lesion could not be covered fully with the stents, therefore the an 8x30mm smart control stent as delivered to the target lesion to cover entire lesion.However the stent got stuck with the implanted-stent (8x40mm smart control stent) and the implanted stent was moved distally.Therefore the 8x30mm smart control stent was removed from the patient and an 8x80mm stent was implanted in order to cover the entire lesion.The procedure finished successfully.There was no reported patient injury.The product was clinically used.And it will be returned for analysis.The stent was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The length of the lesion is unknown.There is no information on if the vessel was predilated.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The sds could not past the lesion and stent deployment was not attempted.The stent was easily removed.

Manufacturer Narrative

Event description continued: protrusion of the 8x30 stent was not reported by the customer.However, it was thought that it was highly possible that the stent would be partially deployed in the procedure due to being stuck in the placed stent.The lot number of this device is not available.A patient code for this event captured as "device dislocation" is not available.The device codes of unintended movement remain applicable.This is one of 2 products involved with the reported events and are associated manufacturer report numbers 9616099-2014-00339 and 9616099-2014-00340.

Manufacturer Narrative

While attempting to advance the 8x30mm smart control sds through a previously implanted 8x40mm smart control stent in the superficial femoral artery it became stuck in the previously implanted stent which moved distally.The 8x30 stent was removed and an 8x80mm was deployed to fully cover the lesion.Preliminary evaluation of the 8x30 stent showed that the stent was protruding.The lesion had heavy calcification and moderate tortuousity with a 100% stenosis.A contralateral approach was made from the right femoral artery.After the lesion was pre-dilated, two smart controls (8/150mm, 8/40mm) were implanted.However the lesion was not covered fully with the stents, therefore the 8x30mm smart control stent as delivered to the target lesion in order to cover entire lesion.However the stent got stuck with the 8x40mm smart control stent and the implanted stent was moved distally.Therefore the 8x30mm smart control stent was removed from the patient and an 8x80mm stent was implanted in order to cover the entire lesion.The procedure finished successfully with no reported patient injury.The stent was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The length of the lesion is unknown.There is no information if the vessel was predilated.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The sds could not past the lesion and stent deployment was not attempted.The stent was easily removed.Stent protrusion of the 8x30 stent was not reported by the customer.However, it was thought that it was highly possible that the stent would be partially deployed in the procedure due to being stuck in the placed stent.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.It is possible that the operator's interaction with the sds may have contributed to the reported event if the deployment steps as listed in the ifu were not followed correctly.Pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, or through another device, can cause the outer member to compress, thus contributing to premature stent deployment/stent jumping while the locking pin is still in.With the information available it appears that device interaction may have been responsible for the slight protrusion of the stent from the outer member and was the cause of the device dislocation.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.This is one of 2 products involved with the reported events and are associated manufacturer report numbers 9616099-2014-00339 and 9616099-2014-00340.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3827420
• MDR Text Key: 4399376
• Report Number: 9616099-2014-00340
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C08040SL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMART CONTROL STENTS 8X150 AND 8X30
• Patient Outcome(s): Required Intervention