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 05/16/2023

Event Type  malfunction  

Event Description

As reported, a crease was noted on the 6x40mm smart control stent delivery system.The stent moved forward and did not cover the lesion.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device is expected to be returned for evaluation.

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A crease was noted on the 6x40mm smart control stent delivery system.The stent moved forward and did not cover the lesion.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.There was no reported patient injury.The device was returned for analysis.A non-sterile unit ¿pkg assy 6x040 smart vas120cm¿ was received coiled inside a clear plastic bag.The unit was unpacked to proceed with the evaluation.The unit was returned with the stent fully deployed; the stent was not included in the packaging for analysis.The locking tab was not returned.A kinked condition was observed located approximately on 106 cm from the distal tip.No other outstanding details were observed.Dimensional analysis was performed to verify the usable length of the device and the analysis was found to be within specification.Functional analysis was not performed due to the unit was returned fully deployed.However, the deployment process was simulated activating the mechanism, the unit performed as expected and no anomalies were observed.A product history record (phr) review of lot 18051098 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported as ¿stent delivery system (sds) ~ deployment difficulty-inaccurate placement¿ was not confirmed.The unit was returned fully deployed and the usable length was found within specification.However, the complaint reported by the customer as ¿stent delivery system (sds) - kinked/bent¿ was confirmed.A kinked condition was observed on the returned device.The exact cause of this kink could not be conclusive determined during the product analysis.Procedural or handling factors might have contributed to this issue.Procedural and or handling factors may have led to the noted kink on the device.According to the instructions for use (ifu), ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ the product analysis does not suggest that the noted damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

A product history record (phr) review of lot18051098 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SMART CONTROL
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17108085
• MDR Text Key: 318099182
• Report Number: 9616099-2023-06521
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: C06040MV
• Device Lot Number: 18051098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2021
• 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