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

Catalog Number C08100SL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: guiding sheath (6f*55cm ansel cook), 4f sheath introducer , guidewire (jupiter, boston scientific), (b)(6).This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During an interventional procedure after an 8x100 iliac smart control stent was placed at the lesion it formed spirals and did not deploy.It was inflated with a balloon catheter and a non cordis stent was placed inside of it.The device will not returned for analysis.The target lesion was the left external iliac artery.The lesion was moderately calcified and tortuous.The rate of stenosis was 100%.The back-up was performed over a guiding sheath (6f 55cm ansel cook) from the right inguinal region.A 4f sheath introducer was punctured from the left side and a guidewire (jupiter, boston scientific) was approached to the occlusion part from both sides.After the guidewire was crossed from left to right, pre-dilation was performed with a balloon catheter (4mmx10cm).Ivus was performed and a the smart control stent was placed at the lesion.However it was placed as form into spirals at the middle and it almost did not deploy.Therefore it was inflated with a balloon catheter (6mmx2cm).Furthermore the stent recoiled when the balloon was deflated.Therefore a stent (8mmx10cm non cordis stent) was placed in the stent.A balloon (6mmx2cm) was inflated and was confirmed by ivus.The inner cavity acquired enough as 6mm so the procedure was completed.There was no reported patient injury.The physician was very experienced with the smart control stent.He did not twist or anything when the stent was placed.It was placed as usual.The product 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.It is unknown if there was any difficulty encountered while advancing/tracking the sds towards the lesion, if any unusual force was used at any time during the procedure, if the smart control locking pin was in place during advancement towards the lesion and if the locking pin was removed before attempting to deploy the smart control stent.It is also unknown if the sds advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user held the handle of the smart control sds flat and straight outside the patient per the ifu.

Manufacturer Narrative

During an interventional procedure after an 8 x 100 iliac smart control stent was placed at the lesion it formed spirals and did not deploy.It was inflated with a balloon catheter and a non cordis stent was placed inside of it.The target lesion was the left external iliac artery.The lesion was moderately calcified and tortuous.The rate of stenosis was 100%.The back-up was performed over a guiding sheath from the right inguinal region.A 4f sheath introducer was punctured from the left side and a guidewire was approached to the occlusion part from both sides.After the guidewire was crossed from left to right, pre-dilation was performed with a balloon catheter (4mm x 10cm).Ivus was performed and the smart control stent was placed at the lesion.However it was placed as form into spirals at the middle and it almost did not deploy.Therefore it was inflated with a balloon catheter (6mm x 2cm).Furthermore the stent recoiled when the balloon was deflated.Therefore a stent (8mm x 10cm non cordis stent) was placed in the stent.A balloon (6mm x 2cm) was inflated and was confirmed by ivus.The inner cavity attained 6mm so the procedure was completed.There was no reported patient injury.The physician was very experienced with the smart control stent.He did not twist or anything when the stent was placed.It was placed as usual.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.It is unknown if there was any difficulty encountered while advancing/tracking the sds towards the lesion, if any unusual force was used at any time during the procedure, if the smart control locking pin was in place during advancement towards the lesion and if the locking pin was removed before attempting to deploy the smart control stent.It is also unknown if the sds advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user held the handle of the smart control sds flat and straight outside the patient per the ifu.The device was not returned for analysis.A device history record (dhr) review of lot 17119149 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent incomplete expansion - (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of moderate calcification, tortuosity and a rate of stenosis of 100% may have contributed to the reported event.According to the ifu ¿verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target stricture.Ensure that the introducer sheath does not move during deployment.Remove locking pin from handle.Initiate stent deployment by rotating the tuning dial with thumb and index finger in a clockwise direction (direction of arrow) while holding the handle in a fixed position.Note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.While using fluoroscopy, maintain position of the radiopaque stent markers relative to the targeted stricture site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is deploying.Continue turning the tuning dial to cause further separation of the distal radiopaque markers until the distal end of the stent obtains full wall apposition.With the distal end of the stent apposing the vessel wall and continuing to maintain a fixed handle position, pull back the deployment lever to deploy the remainder of the stent.Deployment is complete when the proximal markers oppose the vessel wall and the outer sheath radiopaque marker is proximal to the inner shaft stent.Note: when more than one stent is required to open the stricture, the more distal stent should be placed first.Overlap of sequential stents is necessary but the amount of overlap should be kept to a minimum.Post-deployment stent dilatation - advance the deployment lever to its pre-deployment position while maintaining the handle in a fixed position.Recover the delivery system by pushing the lever as far forward as possible and then turning the dial counter-clockwise, while keeping pressure on the lever, until the lever reaches the end of the slot and the tip is resheathed.While using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire, into the catheter sheath introducer and out of the body.Remove the delivery device from the guidewire.Using fluoroscopy, visualize the stent to verify full deployment.If incomplete expansion exists within the stent at any point along the stricture, post deployment balloon dilatation (standard pta technique) can be performed.Note: only areas within the stent length should receive post-deployment balloon dilatation.Select an appropriate size pta balloon catheter and dilate the stricture with conventional technique.The inflation diameter of the pta balloon used for post dilatation should approximate the diameter of the reference vessel.Remove the pta balloon from the patient.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; 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: 5617673
• MDR Text Key: 43983917
• Report Number: 9616099-2016-00207
• 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: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: C08100SL
• Device Lot Number: 17119149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR