MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X30; STENT, ILIAC

Model Number C10030SL

Device Problems Difficult or Delayed Positioning (1157); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  Injury  

Event Description

As reported, the physician was deploying the smart control iliac 10x30 stent; however, the physician visualized that the struts and radiopaque markers of the stent and stopped to confirm positioning under fluoro before deployment, he was not moving the roller in any direction, during that pause is when the physician noticed the stent had slid/ jumped off the deployment system.Another stent had to be placed as the stent had moved too far forward and missed the landing zone for the lesion.The additional stent expand fully with good wall apposition.There was no reported injury to the patient.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The stent was constrained within the outer member/sheath after removed from the package.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock or while flushing the sds.The lesion was noted to have moderate calcification with no vessel tortuosity.The device was not being used to treat a chronic total occlusion.A 6f cordis sheath was used for the procedure.The smart control locking pin was in place during advancement towards the lesion.It was noted that the locking pin was not removed before attempting to deploy the smart control stent.There was no resistance/friction during advancement towards the lesion.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The handle was straight and flat outside the patient, as the ifu instructs.The tantalum markers were observed to be open symmetrically.There was no difficulty or resistance during deployment noted.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18081410 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The physician was deploying the smart control iliac 10x30 stent; however, the physician visualized that the struts and radiopaque markers of the stent and stopped to confirm positioning under fluoroscopy before deployment, he was not moving the roller in any direction, during that pause is when the physician noticed the stent had slid/ jumped off the deployment system.Another stent had to be placed as the stent had moved too far forward and missed the landing zone for the lesion.The additional stent expands fully with good wall apposition.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The stent was constrained within the outer member/sheath after removed from the package.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock or while flushing the sds.The lesion was noted to have moderate calcification with no vessel tortuosity.The device was not being used to treat a chronic total occlusion.A 6f cordis sheath was used for the procedure.The smart control locking pin was in place during advancement towards the lesion.It was noted that the locking pin was not removed before attempting to deploy the smart control stent.There was no resistance/friction during advancement towards the lesion.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The handle was straight and flat outside the patient, as the ifu instructs.The tantalum markers were observed to be open symmetrically.There was no difficulty or resistance during deployment noted.There was no reported injury to the patient.The product was not returned for analysis.A product history record (phr) review of lot 18081410 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 - premature/in patient¿ and ¿stent-ses~ migration¿ were not confirmed.The device was not returned for analysis, and neither were procedural film/images.Vessel characteristics of moderate calcification and procedural factors such as the user¿s interaction with the device during use likely contributed to the reported events.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ additionally, slack removal: advance the stent delivery system past the lesion site, 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 lesion site.Ensure that the stent delivery system 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 lesion site.Note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.Note: the stent may be deployed using two hands (¿pin and pull¿ method) by holding the proximal end of the handle stationary with one hand and sliding the deployment lever back towards the stationary hand.Stent deployment is complete when the proximal markers appose to the vessel wall and the outer sheath radiopaque marker is proximal to the inner shaft stent stop.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the physician was deploying the smart control iliac 10x30 stent; however, the physician visualized that the struts and radiopaque markers of the stent and stopped to confirm positioning under fluoro before deployment, he was not moving the roller in any direction, during that pause is when the physician noticed the stent had slid/ jumped off the deployment system.Another stent had to be placed as the stent had moved too far forward and missed the landing zone for the lesion.The additional stent expand fully with good wall apposition.There was no reported injury to the patient.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The stent was constrained within the outer member/sheath after removed from the package.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock or while flushing the sds.The lesion was noted to have moderate calcification with no vessel tortuosity.The device was not being used to treat a chronic total occlusion.A 6f cordis sheath was used for the procedure.The smart control locking pin was in place during advancement towards the lesion.It was noted that the locking pin was not removed before attempting to deploy the smart control stent.There was no resistance/friction during advancement towards the lesion.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The handle was straight and flat outside the patient, as the ifu instructs.The tantalum markers were observed to be open symmetrically.There was no difficulty or resistance during deployment noted.The device will not be returned for evaluation.

• Brand Name: SMART CONTROL, ILIAC 10X30
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14465473
• MDR Text Key: 292728049
• Report Number: 9616099-2022-05652
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024577
• UDI-Public: (01)20705032024577(17)231231(10)18081410
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: C10030SL
• Device Catalogue Number: C10030SL
• Device Lot Number: 18081410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Date Device Manufactured: 01/21/2022
• 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
• Treatment: 6F CORDIS SHEATH.; UNK STENT.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female