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

Model Number C07040ML

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

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

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.Device will not be returned.

Event Description

As reported, the smart control stent was attempted to be delivered to the lesion, but the distal tip was frayed.The complaint device was replaced with another, bigger sized smart stent.There was no reported injury to the patient.This was an iliac case.Pre-dilation was performed.The product was stored and handled according to the instructions for use (ifu).The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when the device was removed from the tray.A non-cordis sheath was used for the procedure.The device will not be returned for evaluation.

Event Description

As reported, the smart control stent was attempted to be delivered to the lesion, but the distal tip was frayed.The complaint device was replaced with another, bigger sized smart stent.There was no reported injury to the patient.This was an iliac case.Pre-dilation was performed.The product was stored and handled according to the instructions for use (ifu).The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when the device was removed from the tray.A non-cordis sheath was used for the procedure.The device will not be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6 a smart control stent was attempted to be delivered to the lesion, but the distal tip was frayed.The complaint device was replaced with another, bigger sized smart stent.This was an iliac case.Pre-dilation was performed.The product was stored and handled according to the instructions for use (ifu).The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when the device was removed from the tray.A non-cordis sheath was used for the procedure.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18066916 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip- frayed/split/torn¿ was not confirmed.The device was not returned for analysis, and neither were procedural film/images.The exact cause could not be determined.Handling and or procedural factors such as the user¿s interaction with the device or vessel characteristics may have contributed to the reported event.The instructions for use (ifu) state ¿note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the phr review, nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL ILIAC
• Type of Device: 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 ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16860738
• MDR Text Key: 314527656
• Report Number: 9616099-2023-06481
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023792
• UDI-Public: (01)20705032023792(17)231031(10)18066916
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2023
• Device Model Number: C07040ML
• Device Catalogue Number: C07040ML
• Device Lot Number: 18066916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2021
• 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: SABER; SMART; VASSALLO