MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 7X60ML; STENT, ILIAC

Catalog Number C07060ML

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices: 6f destination guiding sheath, terumo; 0.014inch 300cm aguru guidewire, boston scientific; and 4x40mm rxgenity, kaneka.The device is expected to be returned for analysis, but it has not yet been received.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when the outer shaft of a 7x60mm smart control stent delivery system (sds) was withdrawn, 2 to 3 cm of its proximal side would not deploy.The physician slid the outer shaft several times and the entire stent gradually deployed after approximately one minute.A balloon catheter inflated as a post-dilatation.The procedure finished successfully.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The patient¿s information was unknown.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.There were no damages or anomalies noted to the device or packaging prior to use, and there was no difficulty experienced as the device was removed from the packaging.There device was stored, inspected, handled and prepped according to the instructions for use (ifu), and the stent was still constrained within the outer member when removed from packaging.The access site was unknown; however a contralateral approach was made.A non-cordis guiding sheath was delivered to the other side, and a non-cordis 0.014 inch guide wire crossed the lesion.A non-cordis 4x40mm balloon catheter inflated as a pre-dilatation, and the 7x60mm smart control stent was delivered to the lesion.It is unknown if the sd passed through any acute bends or through any previously placed stents.It is unknown if there was any thrombus present around the lesion.It is unknown if there was any difficulty encountered while advancing/tracking the sds to and across the lesion.The locking pin was removed prior to deployment, but it is unknown if all the slack was removed or if the user maintained a fixed inner shaft position during deployment.When its outer shaft was withdrawn, 2 to 3 cm of its proximal side would not deployed.The physician slid its outer shaft several times, then entire stent gradually deployed and it took approximately 1 minute to deploy completely.It is unknown if there was any unusual force or excessive torquing.It is unknown if there was any difficulty removing the device from the patient or if there were any damages/anomalies noted to the device after removal.A balloon catheter inflated as a post-dilatation.

Manufacturer Narrative

The device was received for analysis.Device available for evaluation? was updated accordingly.The engineering report is not yet available; however, it will be provided within 30 days upon receipt.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.  additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: when the outer shaft of a 7 x 60 mm smart control stent delivery system (sds) was withdrawn, 2 to 3 cm of its proximal side would not deploy.The physician slid the outer shaft several times and the entire stent gradually deployed after approximately one minute.A balloon catheter was inflated as a post-dilatation.The procedure finished successfully.There was no reported patient injury.The patient¿s information was unknown.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuosity and calcification is unknown.The rate of stenosis is unknown.There were no damages or anomalies noted to the device or packaging prior to use, and there was no difficulty experienced as the device was removed from the packaging.The device was stored, inspected, handled and prepped according to the instructions for use (ifu), and the stent was still constrained within the outer member when removed from packaging.The access site was unknown; however a contralateral approach was made.A non-cordis guiding sheath was delivered to the other side, and a non-cordis 0.014 inch guide wire crossed the lesion.A non-cordis 4 x 40 mm balloon catheter inflated as a pre-dilatation, and the 7 x 60 mm smart control stent was delivered to the lesion.It is unknown if the sd passed through any acute bends or through any previously placed stents.It is unknown if there was any thrombus present around the lesion.It is unknown if there was any difficulty encountered while advancing/tracking the sds to and across the lesion.The locking pin was removed prior to deployment, but it is unknown if all the slack was removed or if the user maintained a fixed inner shaft position during deployment.When its outer shaft was withdrawn, 2 to 3 cm of its proximal side would not deployed.The physician slid its outer shaft several times, then entire stent gradually deployed and it took approximately 1 minute to deploy completely.It is unknown if there was any unusual force or excessive torquing.It is unknown if there was any difficulty removing the device from the patient or if there were any damages/anomalies noted to the device after removal.A balloon catheter was inflated as a post-dilatation.  the product was returned for analysis.One non-sterile smart control, iliac 7 x 60 mm sds catheter was returned.No original packaging was returned.The locking pin had been removed from the unit and was not returned.  the stent had been deployed and remains implanted in the patient.Per visual analysis, the inner member was noted to be deployed 5 cm at distal.Also, a kink was noted on the outer member at 6.5 cm from the id band.No other anomalies were noted.Per functional analysis neither difficulty nor resistance on rotating the tuning dial was felt or experienced.A device history record (dhr) review of lot 17259965 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.  the reported ¿stent delivery system (sds)-ses-deployment difficulty - partial deployment¿ was not confirmed through analysis of the returned device as the stent was not present and had been successfully implanted in the patient.The exact cause of the event could not be determined during analysis.Based on the limited information available for review, it is not possible to determine whether vessel characteristics or procedural factors contributed to the reported event; however a kink noted on the outer member of the devices may be an indication of such factors.According to the instructions for use ¿do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Introduction of stent delivery system a.Ensure locking pin is still in place.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an introducer sheath for the implant procedure, to protect puncture site.An introducer sheath of a 6f (2.0 mm) or larger size is recommended.Slack removal a.Advance the stent delivery system past the stricture site.B.Pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the target stricture.C.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft, either outside or inside the patient, may result in deploying the stent beyond the target stricture site.Stent deployment a.Verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target stricture.B.Ensure that the introducer sheath does not move during deployment.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 7X60ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6202701
• MDR Text Key: 63233345
• Report Number: 9616099-2016-00814
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2017

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: 04/30/2017
• Device Catalogue Number: C07060ML
• Device Lot Number: 17259965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/09/2016
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2017; 02/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1