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

Catalog Number SR08100XL

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

As reported, after implantation of an 8mm x 100mm smart radianz self-expanding stent (ses), when removing the delivery system from the patient over a 300cm vassallo floppy guidewire, it was noticed that the front end was torn off.The 10cm separated segment remained on the vassallo guidewire and was able to be removed without issue by pulling the guidewire.Additionally, there was some resistance when removing the delivery system due to resistance with the guidewire.The procedure continued by implanting a 7mm x 60mm smart vascular ses at the external iliac artery (eia).The right common iliac artery was then treated, and the procedure was completed.There were no reported injuries to the patient.This was during a procedure to treat two separate lesions, one in the left common iliac artery to external iliac artery (eia), and one in the right common iliac artery to superficial femoral artery (sfa).The eia lesion had a stenosis of 85% - 95% and was moderately calcified.The sfa lesion had a stenosis of 90%-100% and was moderately calcified.A 6f 90cm non-cordis guiding sheath was used for access from the left brachial artery to the left iliac artery.Various unknown guidewires were used and were able to pass.An unknown balloon catheter was used for pre-dilation.The smart radianz ses delivery system was stored and prepped per the instructions for use (ifu).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 RADIANZ
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 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: 19201032
• MDR Text Key: 341999049
• Report Number: 9616099-2024-00129
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032082393
• UDI-Public: 20705032082393
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SR08100XL
• Device Lot Number: 18276284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2024
• 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: 7MM X 60MM SMART VASCULAR SES.; DESTINATION (6F*90CM, TERUMO).; GUIDEWIRE (0.018 300CM.; SHEATH (6GDF).; VASSALLO FLOPPY.