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

Catalog Number C08060SL

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

As reported, when delivering an 8mm x 60mm smart control iliac self-expanding stent (ses) delivery system directly to the lesion, the delivery system was caught within the vessel prior to reaching the lesion and could not cross the lesion.After removing the device, it was noticed that the distal tip was frayed.As a result, a different sized smart ses delivery system was used as a replacement and was implanted.There were no reported injuries to the patient.This was during a procedure to treat a 90% stenosed iliac lesion which had mild calcification and mild tortuosity.The device was stored, prepped, and handled per the instructions for use (ifu) and there were no damages to the device prior to entering the patient.The delivery system was able to be removed easily from the patient and remained in one piece during its removal.The stent was still properly mounted on the delivery system upon removal from the patient.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, when delivering an 8mm x 60mm smart control iliac self-expanding stent (ses) delivery system directly to the lesion, the delivery system was caught within the vessel prior to reaching the lesion and could not cross the lesion.After removing the device, it was noticed that the distal tip was frayed.As a result, a different sized smart ses delivery system was used as a replacement and was implanted.There were no reported injuries to the patient.This was during a procedure to treat a 90% stenosed iliac lesion which had mild calcification and mild tortuosity.The device was stored, prepped, and handled per the instructions for use (ifu) and there were no damages to the device prior to entering the patient.The delivery system was able to be removed easily from the patient and remained in one piece during its removal.The stent was still properly mounted on the delivery system upon removal from the patient.The device will not be returned for evaluation.The reported ¿stent delivery system (sds) tracking difficulty and catheter tip frayed/split/torn¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.Difficulty crossing a lesion, or an anatomical structure and/or stent is a known procedural occurrence.Crossing difficulty is most commonly related to patient anatomy, operator technique and appropriate device selection.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.

• 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: 18806882
• MDR Text Key: 337625880
• Report Number: 9616099-2024-00065
• 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
• Type of Report: Initial
• Report Date: 02/29/2024

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 Catalogue Number: C08060SL
• Device Lot Number: 18235728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: NEW SMART SES (DIFFERENT SIZE).