MAUDE Adverse Event Report: CORDIS US. CORP SMART CONTROL ILIAC; STENT, ILIAC

Catalog Number C10030SL

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

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

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Compliant conclusion: as reported, an approach from the right brachial region was made with a 10mm x 30mm smart control self-expanding stent (ses) delivery system.When deploying the 10mm x 30mm smart control ses at the brachiocephalic artery, the stent jumped forward towards the aorta (ao).The stent remained stuck on a vassallo guidewire being used for the procedure and was able to be successfully retrieved using an unknown biopsy forceps from a second femoral access point.It was also reported that there was difficulty removing the delivery system from the patient.After removing the smart control ses, a non-cordis stent was implanted at the brachiocephalic artery to complete the procedure over the same vassallo guidewire.The device was stored and prepped per the instructions for use (ifu).The lesion had mild calcification, mild tortuosity, and a 90% stenosis.The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempted deployment.The delivery system was advanced past the lesion and then withdrawn into the lesion.The handle of the device was held flat and straight outside of the patient.A 7f non-cordis catheter sheath introducer (csi) was used for brachial access.An unknown intravascular ultrasound (ivus) device was used during this procedure.The device will not be returned for evaluation.The reported ¿stent delivery system (sds) deployment difficulty inaccurate placement and stent delivery system (sds) withdrawal difficulty¿ cannot be confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely procedural and handling factors contributed to the event reported.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, which is not intended as a mitigation of risk, for smart control, ¿ensure locking pin is still in place.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.Advance the stent delivery system over the guidewire through the sheath introducer to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an appropriate size introducer sheath for the implant procedure to protect vessel and access site.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.¿ the information available does not suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, an approach from the right brachial region was made with a 10mm x 30mm smart control self-expanding stent (ses) delivery system.When deploying the 10mm x 30mm smart control ses at the brachiocephalic artery, the stent jumped forward towards the aorta (ao).The stent remained stuck on a vassallo guidewire being used for the procedure and was able to be successfully retrieved using an unknown biopsy forceps from a second femoral access point.It was also reported that there was difficulty removing the delivery system from the patient.After removing the smart control ses, a non-cordis stent was implanted at the brachiocephalic artery to complete the procedure over the same vassallo guidewire.The device was stored and prepped per the instructions for use (ifu).The lesion had mild calcification, mild tortuosity, and a 90% stenosis.The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempted deployment.The delivery system was advanced past the lesion and then withdrawn into the lesion.The handle of the device was held flat and straight outside of the patient.A 7f non-cordis catheter sheath introducer (csi) was used for brachial access.An unknown intravascular ultrasound (ivus) device was used during this procedure.The device will not be returned for evaluation.

• Brand Name: SMART CONTROL ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18696565
• MDR Text Key: 335261477
• Report Number: 9616099-2024-00052
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C10030SL
• Device Lot Number: 18126699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: IVUS; PARENT; VBX
• Patient Outcome(s): Required Intervention