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

Catalog Number C07060SL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the gender of the patient is unknown.Gtin# (b)(4).The device has been received, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the sales rep, there was deployment difficulty of a smart control stent.Physician was required to place an additional stent to cover the narrowing at the end of the stent caused by the difficulty to completely unsheath it.There was no patient injury.The intended procedure was a venous intervention.The target lesion was located in the arm with no calcification, or vessel tortuosity.The lesion was not angulated or located along a bifurcation.There were no damages or anomalies noted to the device prior to removal from packaging, and no damages noted to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging, and the product was stored, inspected, handled and prepped according to the instructions for use (ifu).The access site was located in the brachial and an ipsilateral approach was made.There was no difficulty encountered while advancing/tracking the sds towards the lesion or crossing the lesion with the stent.However, the sds did pass through acute bends, but it did not have to pass through a previously placed stent.Unusual force and excessive torqueing was not used at any time during the procedure.All the slack was removed from the sds prior to attempting to deploy and there was no difficulty turning the tuning dial.There was no thrombus present proximal to, at, or distal to the lesion site.The physician was required to pull aggressively to release the remaining section of the stent to release it from the catheter.The narrowing on the end of the stent was unable to be treated with balloon angioplasty; therefore a smart control stent was implanted at the narrowed area.There were no damages or anomalies noted to the outer sheath or the deployment system after use.There was no difficulty removing the device from the patient.

Manufacturer Narrative

Complaint conclusion: there was deployment difficulty of a smart control stent.The physician was required to place an additional stent to cover the narrowing at the end of the stent caused by the difficulty to completely unsheath it.There was no patient injury.The intended procedure was a venous intervention.The target lesion was located in the arm with no calcification, or vessel tortuosity.The lesion was not angulated or located along a bifurcation.There were no damages or anomalies noted to the device prior to removal from packaging, and no damages noted to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging, and the product was stored, inspected, handled and prepped according to the instructions for use (ifu).The access site was located in the brachial and an ipsilateral approach was made.There was no difficulty encountered while advancing/tracking the sds (stent delivery system) towards the lesion or crossing the lesion with the stent.However, the sds did pass through acute bends, but it did not have to pass through a previously placed stent.Unusual force and excessive torqueing was not used at any time during the procedure.All the slack was removed from the sds prior to attempting to deploy and there was no difficulty turning the tuning dial.There was no thrombus present proximal to, at, or distal to the lesion site.The physician was required to pull aggressively to release the remaining section of the stent to release it from the catheter.The narrowing on the end of the stent was unable to be treated with balloon angioplasty; therefore a smart control stent was implanted at the narrowed area.There were no damages or anomalies noted to the outer sheath or the deployment system after use.There was no difficulty removing the device from the patient.The product was returned for analysis.A non-sterile unit of smart control, iliac 7x60 sds was returned.Per visual analysis the stent was not returned.A kink condition was observed on the catheter body at 1.5 cm from the id band.A kink condition was observed on the clear section and inner member at 5.5 cm from the distal tip.Blood residuals were observed inside the catheter.The locking pin was not returned in the handle.Per functional analysis no anomalies were found.Per microscopic analysis the kinks were confirmed.A device history record (dhr) review of lot 17414573 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)/ deployment difficulty¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully and the stent was not returned.The exact cause of the reported event could not be determined.The reported ¿stent incomplete expansion - (peripheral)¿ was not confirmed by analysis of the returned device as no procedural films were available and the stent was not returned.Procedural or handling factors may have contributed to the event as evidenced by kinks on the device indicating the application of force.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.B.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.¿ the device performed as intended and therefore the reported event and the dhr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• 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: 5758345
• MDR Text Key: 48444457
• Report Number: 9616099-2016-00411
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: C07060SL
• Device Lot Number: 17414573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention