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

Catalog Number C10060ML

Device Problem Difficult to Remove (1528)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

As reported, the black deployment dial on a 10mm x 60mm smart control iliac self-expanding stent (ses) delivery system did not deploy the stent when dialed in the correct direction and there was resistance/friction when turning the dial.As a result, the stent was deployed fully with the trigger without any resistance felt.Additionally, the device was somewhat difficult to remove.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion.A pedal access approach was used for this procedure.The device was stored and prepped per the instructions for use (ifu).The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempting to deploy the stent.The sds was advanced past the lesion and was withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, b5, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the black deployment dial on a 10mm x 60mm smart control iliac self-expanding stent (ses) delivery system did not deploy the stent when dialed in the correct direction and there was resistance/friction when turning the dial.As a result, the stent was deployed fully with the trigger without any resistance felt.Additionally, the device was somewhat difficult to remove.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion.A pedal access approach was used for this procedure.The device was stored and prepped per the instructions for use (ifu).The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempting to deploy the stent.The sds was advanced past the lesion and was withdrawn back into the lesion prior to stent deployment.The device was returned for analysis.A non-sterile ¿smart control, iliac 10x60ml¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was returned fully deployed and the stent was not returned for analysis.In addition, an inner sheath separation is observed located approximately 32.5cm from the inner member hub.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to identify the measurement of the separated area and to verify the id/od measurement near the separated area.Dimensional analysis results were found within specification.Functional testing related to stent deployment, could not be conducted because the unit was returned fully deployed and due to the observed separation condition on the inner sheath.However, the functional test for tuning dial rotation was successfully carried out.It's important to note that no damages or anomalies were observed during this test.In addition, insertion/withdrawal difficulty testing was executed successfully using a csi lab sample, no anomalies were observed during the test.Sem analysis was not performed as the damages associated with the separation are visible with the magnification obtained with a vision system.The separated area was analyzed using a vision system to magnify the damaged area.Results showed the edges on the separated area presented evidence of elongations.These elongations are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the prosthesis material was induced to a tensile force/pulling event that exceeded the body/shaft material yield strength prior to the separation.The reported "stent delivery system (sds) withdrawal difficulty" was not confirmed during device analysis.The sds was received fully deployed and the stent itself was unavailable for evaluation.In addition, no anomalies were observed during insertion/withdrawal testing using a lab sample csi and due to the nature of the complaint, this cannot be replicated in a lab as vessel characteristics, technique and procedural factors can contribute to a withdrawal difficulty.The reported ¿inner shaft- separated¿ was confirmed as a separated condition of the inner shaft was observed.Dimensional analysis indicated the measurements were within specification.However, it is suspected the material may have been induced to a tensile force exceeding its yield strength prior to the separation, as evidenced by the elongations and twist observed at the edges of the separated area.The reported ¿tuning dial (smart control only)- rotation difficulty¿, was not confirmed since the functional test for the tuning dial rotation was successfully carried out; additionally, it is important to note that no damages or anomalies were observed during this test.Based on the information available for review, and product analysis, it is not possible to determine what factors may have contributed to the issues experienced by the customer.However, there were no problems deploying the stent; therefore, it is likely procedural factors and handling of the device contributed to the events involving the returned device.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu cautions, ¿when catheters are in the body, they should be manipulated using high quality radiographic equipment.Prior to stent deployment, remove all slack from catheter delivery system (see ¿stent deployment/ procedure¿).As stated in the ifu, 4.Slack removal, ¿advance the stent delivery system past the lesion site.Pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion site.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the target lesion site.After removing the locking pin ¿deployment is initiated by rotating the tuning dial with the thumb and index finger in a clockwise direction until the distal stent markers and the distal end of the stent, visibly appose the vessel wall.With the distal stent markers and the distal end of the stent apposing the vessel wall, stent deployment continues by pulling back on the deployment lever.Complete deployment of the stent is achieved when the proximal end of the stent and the proximal stent markers visibly appose the vessel wall, and the outer sheath radiopaque marker is proximal to the inner shaft stent stop¿.¿ the information available does not suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the black deployment dial on a 10mm x 60mm smart control iliac self-expanding stent (ses) delivery system did not deploy the stent when dialed in the correct direction and there was resistance/friction when turning the dial.As a result, the stent was deployed fully with the trigger without any resistance felt.Additionally, the device was somewhat difficult to remove.There were no reported injuries to the patient.This was during a procedure to treat a superficial femoral artery (sfa) lesion.A pedal access approach was used for this procedure.The device was stored and prepped per the instructions for use (ifu).The smart control locking pin was in place during advancement towards the lesion and was removed prior to attempting to deploy the stent.The sds was advanced past the lesion and was withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.Addendum: product evaluation revealed an inner shaft - separation of the smart control ses delivery system.

• Brand Name: SMART CONTROL ILIAC
• 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 ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18865748
• MDR Text Key: 337213051
• Report Number: 9616099-2024-00077
• Device Sequence Number: 1
• Product Code: NIO
• 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
• Type of Report: Initial
• Report Date: 03/08/2024

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 Catalogue Number: C10060ML
• Device Lot Number: 18221971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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