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

Catalog Number C06100ML

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Hold for ac 4.21 as reported, the account stated that the 6x100 smart control iliac vascular stents "foreshortened" and were damaged during delivery.The physician reports patient movement during deployment causing "bunching" which was noted after delivery.There was no reported patient injury.The product packaging was discarded; therefore, the lot number could not be obtained.There was no packaging damage or product and the sterile pouch received was not compromised.The device was stored in the lab as per the instructions for use (ifu).The device will not be returned for evaluation.

Manufacturer Narrative

The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The account stated that the 6x100 smart control iliac vascular stent "foreshortened" and was damaged during delivery.The event involved one device.The physician reports patient movement during deployment causing "bunching" which was noted after delivery.The product packaging was discarded; therefore, the lot number could not be obtained.There was no packaging damage or product and the sterile pouch received was not compromised.The device was stored in the lab as per the instructions for use (ifu).Target lesion characteristics before pre-dilation included mild calcification and tortuosity.The degree of stenosis was not provided.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The target lesion vessel diameter and the target lesion vessel length were not provided.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.The sds did not have to pass through a previously placed stent.There was no difficulty encountered flushing the sds.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.Other information was requested; however, the information could not be obtained.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review could not be conducted as the lot numbers was not provided.Without the return of the device for analysis and based on the information provided, the reported ¿stent-ses - incorrect length¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics (although unknown) and or the user¿s interaction with the device may have led to the reported event.The instructions for use (ifu) advises that during placement, it is imperative that the treating physician holds the deployment handle in a fixed position during the entire deployment.If the handle is moved forward or backward after the stent has achieved initial wall apposition, then segments of compression or expansion can be created.This can result in stent lengths which are longer or shorter than expected.Based on the information provided, there is no information available to suggest a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• 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 FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16778799
• MDR Text Key: 313821750
• Report Number: 9616099-2023-06469
• 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,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C06100ML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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