MAUDE Adverse Event Report: CORDIS US. CORP SMART CONTROL; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number C06040MV

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/20/2023

Event Type  malfunction  

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.

Event Description

As reported, the 6x040 smart vas 120cm stent could not be released normally.The stent was noted to have been partially deployed.The case was completed with the use of an unknown device/product.There was no reported injury to the patient.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 was 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 after removal from the tray.There was no difficulty encountered while flushing the sds.The lesion was noted to have mild calcification.The vessel had moderate tortuosity.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.As reported, the 6x040 smart control vas 120cm stent could not be released normally.The stent was noted to have been partially deployed.The case was completed with the use of an unknown device/product.There was no reported injury to the patient.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 was 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 after removal from the tray.There was no difficulty encountered while flushing the sds.The lesion was noted to have mild calcification.The vessel had moderate tortuosity.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The device was returned for analysis.A non-sterile product ¿pkg assy 6x040 smart vas120cm¿ was received coiled inside of a clear plastic bag.The part was unpacked to perform the evaluation.The unit was thoroughly inspected noticing one kink located approximately at 118.0 cm from the distal end.The stent is properly mounted on the device.The device is blood saturated.The locking pin was not returned for analysis.No other damages or anomalies were observed via visual inspection of the device.Dimensional analysis was performed to identify the measurement of the kinked condition.Per device functional analysis, the tuning dial was rotated with the thumb in a clockwise direction (direction indicated by the arrow).The tuning dial was continued to be turned until the distal section of the stent was totally deployed.Then, the deployment lever was pulled back to unsheathe the remainder of the stent.The stent was fully deployed, and no anomalies were observed during this process.The reported event of ¿stent delivery system (sds)-deployment difficulty partial deployment¿ was not confirmed during analysis of the returned device.Visual inspection did not reveal any partial deployment of the stent.The stent was then deployed with no difficulties during functional analysis.The exact cause of the issue experienced by the customer could not be determined.A kink/bent condition was noted on the device when returned; however, this defect was not mentioned in the event description and was likely related to shipping and/or handling factors and did not impede functional analysis of the device.Therefore, based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to issue experienced by the customer.However, since no partial deployment was observed and there were no problems deploying the device, it is likely that procedural/handling factors possibly contributed to the reported event.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 lesion site.Ensure that the stent delivery system 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 lesion site.¿ also, per the indications for use, ¿the cordis s.M.A.R.T.® control® nitinol stent system is indicated for use in patients with atherosclerotic disease of peripheral arteries, including iliac and superficial femoral arteries.¿ usage of the product other than that indicated in the product's ifu may involve additional risks/issues not described in the labeling.The product analysis does not suggest that the issue reported, and condition of the returned device could be related to the design or manufacturing process of the units.Therefore, no corrective or preventative actions will be taken.

Event Description

As reported, the 6x040 smart control vas 120cm stent could not be released normally.The stent was noted to have been partially deployed.The case was completed with the use of an unknown device/product.There was no reported injury to the patient.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 was 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 after removal from the tray.There was no difficulty encountered while flushing the sds.The lesion was noted to have mild calcification.The vessel had moderate tortuosity.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The device will be returned for evaluation.

• Brand Name: SMART CONTROL
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18332969
• MDR Text Key: 330968643
• Report Number: 9616099-2023-06662
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C06040MV
• Device Lot Number: 18201783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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: CORDISC06040MV BRACKET