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

Catalog Number C09040SL

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

An attempt was made to implant a 9x40 smart control iliac stent at the stenosis of the common iliac artery using an ipsilateral retrograde approach; however, the stent jumped and moved central side from the desired location.The complaint device did not cover the lesion; therefore, additional stent(s) were added.The intended procedure was reported to be iliac artery dilatation.There was moderate lesion calcification and tortuosity with seventy-five per cent (75%) stenosis.The device was stored, handled, and prepped per the instructions for use (ifu); there were no difficulties experienced in prepping the device.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.Nothing unusual was noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized 1-2 mm larger than the target area.There was no resistance/friction during insertion of the device.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The stent was left in place.No unusual force was used at any time during the procedure.The area was predilated prior to stent implantation.The procedure was completed successfully without patient injury.The device was not returned for analysis.A product history record (phr) review of lot 18085936 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported stent delivery system- deployment difficulty- inaccurate placement, was not confirmed since the unit was not returned for analysis.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ 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.

Event Description

As reported, an attempt was made to implant a 9x40 smart control iliac stent at the stenosis of the common iliac artery using an ipsilateral retrograde approach; however, the stent jumped and moved central side from the desired location.The complaint device did not cover the lesion; therefore, additional stent(s) were added.The procedure was completed successfully without patient injury.The intended procedure was reported to be iliac artery dilatation.There was moderate lesion calcification and tortuosity with seventy-five per cent (75%) stenosis.The device was stored, handled, and prepped per the instructions for use (ifu); there were no difficulties experienced in prepping the device.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.Nothing unusual was noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized 1-2 mm larger than the target area.There was no resistance/friction during insertion of the device.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The stent was left in place.No unusual force was used at any time during the procedure.The area was predilated prior to stent implantation.The device remains implanted; thus it will not be returned.

• Brand Name: SMART CONTROL ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 17387978
• MDR Text Key: 319828123
• Report Number: 9616099-2023-06557
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024416
• UDI-Public: (01)20705032024416(17)240131(10)1805936
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: C09040SL
• Device Lot Number: 18085936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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: 6F MEDIKIT