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

Catalog Number C10060ML

Device Problem Difficult to Remove (1528)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

As reported, the black deployment dial on a 10mm x 60mm smart control iliac self-expanding stent (ses) delivery system did not deploy the stent when dialed in the correct direction and there was resistance/friction when turning the dial.As a result, the stent was deployed fully with the trigger without any resistance felt.Additionally, the device was somewhat difficult to remove.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion.A pedal access approach was used for this procedure.The device was stored and prepped per the instructions for use (ifu).The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempting to deploy the stent.The sds was advanced past the lesion and was withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SMART CONTROL ILIAC
• 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 ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18865748
• MDR Text Key: 337213051
• Report Number: 9616099-2024-00077
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C10060ML
• Device Lot Number: 18221971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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