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

Catalog Number	SR08100XL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when using an 8mm x 100mm smart radianz self-expanding stent (ses) delivery system, the stent edge could be deployed but the stent could not be deployed.The device was replaced with a new, unknown smart control ses to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat an iliac lesion.The device will not be returned for evaluation.
Event or Problem Description
As reported, when using an 8mm x 100mm smart radianz self-expanding stent (ses) delivery system, the stent edge could be deployed but the stent could not be deployed.The device was replaced with a new, unknown smart control ses to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat an iliac lesion.Additional information was requested but was not provided.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, when using an 8mm x 100mm smart radianz self-expanding stent (ses) delivery system, the stent edge could be deployed but the stent could not be deployed.The device was replaced with a new, unknown smart control ses to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat an iliac lesion.Additional information was requested but was not provided.The device was not returned for evaluation.The reported event of ¿stent delivery system (sds)- deployment difficulty-partial deployment¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to issue experienced by the customer.However, procedural/handling factors are possible.According to the safety information within the instructions for use (ifu), it warns that ¿the stent is not designed for dragging or repositioning.Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.¿ it also cautions, ¿when catheters are in the body, they should be manipulated using high quality radiographic equipment.Prior to stent deployment, remove all slack from catheter delivery system (see ¿stent deployment/ procedure¿).If resistance is felt when beginning deployment, do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ based on the information available for review, there is no indication that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: SMART RADIANZ
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18286177
• Report Number: 9616099-2023-06656
• Device Sequence Number: 6668189
• Product Code: NIO
• UDI-Device Identifier: 20705032082393
• UDI-Public: (01)20705032082393(17)240930(10)18158539
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: SR08100XL
• Device Lot Number: 18158539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 08/14/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/28/2023; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMART CONTROL STENT
• Patient Sex: Unknown