MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X40ML; STENT, ILIAC

Model Number C10040ML

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

As reported, the tuning dial on a 10 x 40ml iliac smart control vascular stent system was unable to be turned all the way.The complaint device was replaced with another different sized device.There were no reports of patient injury.The lesion was the subclavian artery which was stenosed.An approach was made from the femoral artery.A 6fr 90cm non-cordis sheath was used.The smart control device was attempted to be implanted.After the incident, the complaint device was removed from the patient to observe.The outer sheath had been retracted until the stent was about to come out.The tuning dial had been retracted towards the proximal part from the original position.The device will be returned for evaluation.Addendum: a separation on the inner lumen and a severe kink were observed on the returned device.

Manufacturer Narrative

The tuning dial on a 10 x 40ml iliac smart control vascular stent system was unable to be turned all the way.The complaint device was replaced with another different sized device.There were no reports of patient injury.The lesion was the subclavian artery which was stenosed.An approach was made from the femoral artery.A 6fr 90cm non-cordis sheath was used.The smart control device was attempted to be implanted.After the incident, the complaint device was removed from the patient to observe.The outer sheath had been retracted until the stent was about to come out.The tuning dial had been retracted towards the proximal part from the original position.The device was returned for analysis.A non-sterile smart control, iliac 8x80cm stent delivery system was received for analysis inside of a plastic bag.Per visual analysis the unit was fully deployed, and the stent was not returned for analysis.The locking pin was not returned for analysis.A severe kinked/bent condition located approximately at 18.5 cm from the distal tip was noted.No other damages or anomalies were observed.Functional analysis was not performed as the unit was returned fully deployed.However, the tuning dial was rotated with the thumb in both directions to verify the functionally of the deploying system observing that the inner lumen cannot be retracted.This condition is caused due to a separation of the inner lumen occurred where the severe kink is located.Per microscopic analysis the separated area presented evidence of elongations on the edge.The elongations found on the material of the unit are commonly associated with separations caused by material tensile/twisted overload.Therefore, it is assumed that the device was induced to a tensile/twisted force that exceeded the material yield strength prior to the separation.A product history record (phr) review of lot 18092360 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿inner shaft separated¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The reported ¿tuning dial (smart control only) rotation difficulty¿ was not confirmed through analysis of the returned device as it functioned as expected.Based on the information available for review, procedural an/or handling factors may have contributed to the separation, as evidenced by a separation with elongations associated with a severe kink noted on the device during analysis.According to the safety information in the instructions for use ¿the s.M.A.R.T.Control nitinol stent system is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patent profunda or superficial femoral artery.Following dilatation of the lesion, an arteriographic image should be recorded in order to determine the adequacy of the primary procedure.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Initiate stent deployment by rotating the tuning dial with thumb and index finger in a clockwise direction (direction of arrow) while holding the handle in a fixed position.While using fluoroscopy, maintain position of the radiopaque stent markers relative to the targeted stricture site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is deploying.Continue turning the tuning dial to cause further separation of the distal radiopaque markers until the distal end of the stent obtains full wall apposition.With the distal end of the stent apposing the vessel wall and continuing to maintain a fixed handle position, pull back the deployment lever to deploy the remainder of the stent.Deployment is complete when the proximal markers oppose the vessel wall and the outer sheath radiopaque marker is proximal to the inner shaft stent.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: SMART CONTROL, ILIAC 10X40ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15510710
• MDR Text Key: 304537372
• Report Number: 9616099-2022-06034
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024591
• UDI-Public: 20705032024591
• 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: 09/29/2022

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 Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: C10040ML
• Device Catalogue Number: C10040ML
• Device Lot Number: 18092360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: SHEATH (6FR/90CM DESTINATION, TERUMO), UNK DEVICE