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

Catalog Number C09040SL

Device Problems Difficult or Delayed Positioning (1157); Migration (4003)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the physician, the 9x40 smart control iliac stent seemed to jump forward more than was normally expected.The stent migrated approximately 3-4 cm.The stent was left in place in the patient.Additional stents were not needed to complete the procedure; the surgeon stopped further interventions after stent failure.There was no reported patient injury.The device was opened in sterile filed and stored as per labeling.The intended procedure was reported to be an angiogram, angioplasty with stent placement.There was no significant calcification or tortuosity noted with seventy percent (70%) stenosis and thirty percent (30%) post-angioplasty.The area was predilated prior to stent implantation using a non-cordis balloon.The device was handled, and prepped per the instructions for use (ifu) and there was no difficulty experienced in prepping the device.There was nothing unusual 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.No unusual force was used at any time during the procedure.The device is expected to be returned for investigation.

Manufacturer Narrative

A product history record (phr) review of lot 18187442 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported by the physician, the 9x40 smart control iliac stent seemed to jump forward more than was normally expected.The stent migrated approximately 3-4 cm.The stent was left in place in the patient.Additional stents were not needed to complete the procedure; the surgeon stopped further interventions after stent failure.There was no reported patient injury.The device was opened in sterile filed and stored as per labeling.The intended procedure was reported to be an angiogram, angioplasty with stent placement.There was no significant calcification or tortuosity noted with seventy percent (70%) stenosis and thirty percent (30%) post-angioplasty.The area was predilated prior to stent implantation using a non-cordis balloon.The device was handled and prepped per the instructions for use (ifu) and there was no difficulty experienced in prepping the device.There was nothing unusual 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.No unusual force was used at any time during the procedure.The device was returned for analysis.A non-sterile unit of product ¿smart control, iliac 9x40¿ was received coiled inside of a clear plastic bag.The part was unpacked to perform the evaluation.The stent of the unit was already deployed.One kinked/bent condition was observed located approximately at 76 cm from the distal end.No other damages or anomalies were observed at the inspected device.Even though the device was received already deployed, functional analysis was performed to determine the functionally of the unit.The turning dial was rotated with the thumb in a clockwise direction (direction indicated by the arrow).The turning dial was continuously turned until the distal section of the stent was totally deployed.No anomalies were observed during this process.A product history record (phr) review of lot 18187442 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 (sds)- deployment difficulty¿ was not confirmed since no anomalies were noted during the functional test.In addition, the device was received already deployed.However, the complaint can be confirmed as stent delivery system (sds)-kinked-bent since this condition was found at the outer shaft, it is possible that this condition may have caused the reported issue.The reported ¿stent-migration¿ was not confirmed since it is not possible to determine what may have caused the reported issue due to the nature of the complaint.According to the instructions for use (ifu) ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review, nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• 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 ; 7863138372
• MDR Report Key: 17460785
• MDR Text Key: 320871118
• Report Number: 9616099-2023-06570
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024416
• UDI-Public: (01)20705032024416(17)250131(10)18187442
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C09040SL
• Device Lot Number: 18187442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• 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
• Treatment: 9X4 GLADIATOR BALLOON UP TO 16 ATM.
• Patient Age: 71 YR
• Patient Sex: Female