MAUDE Adverse Event Report: CORDIS CORPORATION 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 01/15/2024

Event Type  Injury  

Event Description

As reported, a smart control, iliac 9 mm x 40 mm vascular stent was automatically getting released and the stent was deployed further than intended position.Therefore, an unknown 8 mm x 60 mm stent was added and implanted.The smart stent was being implanted at the common iliac artery.The complaint device was deployed approximate 1 cm and final positioning was being adjusted.However, the stent was automatically getting released and the stent was deployed further than intended position.An unknown 6f short sheath was used.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The stent remained implanted; therefore, it will not be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, a smart control, iliac 9 mm x 40 mm vascular stent was automatically getting released and the stent was deployed further than intended position.Therefore, an unknown 8 mm x 60 mm stent was added and implanted.The smart stent was being implanted at the common iliac artery.The complaint device was deployed approximate 1 cm and final positioning was being adjusted.However, the stent was automatically getting released and the stent was deployed further than intended position.An unknown 6f short sheath was used.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The stent remained implanted; therefore, it will not be returned for evaluation.The reported event of ¿stent delivery system (sds)-deployment difficulty-premature/in patient¿ could not be confirmed as the device was not returned for analysis and procedural films of the reported event was not provided.The exact cause of the issue experienced could not be determined.Based on the information available for review, it is difficult to determine what factors may have contributed to the premature deployment of the stent reported.However, as 1cm of the stent was already deployed and the user was repositioning the device at the time of the issue, it is likely that procedural/handling factors (as the locking pin should be removed at this time) contributed to the reported event of the unintended deployment of the remainder of the stent.According to the instructions for use (ifu), it warns ¿the stent is not designed for repositioning or recapturing.Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.¿ the ifu also instructs during stent deployment, ¿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.Verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target lesion.Ensure that the introducer sheath does not move during deployment.Remove locking pin from handle.Initiate one-handed stent deployment by rotating the tuning dial with thumb and index fingers 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 lesion site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is unsheathed.Continue turning the tuning dial until the distal end of the stent obtains full apposition with the vessel wall.Note: only the initial 40 mm of the stent may be unsheathed using the tuning dial.¿ based on the information available for review, there is no indication that the reported event could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• 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 US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18676294
• MDR Text Key: 335015253
• Report Number: 9616099-2024-00044
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C09040SL
• Device Lot Number: 18226352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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: UNKNOWN 6F SHORT SHEATH.; UNKNOWN 8 MM X 60 CM STENT.
• Patient Outcome(s): Life Threatening; Required Intervention