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

Catalog Number C06080MV

Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18018927 presented no issues during the manufacturing process that can be related to the reported event.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.

Event Description

As reported, after releasing the stent of a 6mm x 80mm smart 120cm vascular self-expanding stent (ses) delivery system, the stent curled up together.When releasing the stent, the knob did not respond and the lever was directly puled to release the stent; however, the stent curled up.The delivery system was then stuck on the unknown guidewire and could not be withdrawn.After several hard attempts, the delivery system was eventually removed.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosed, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) which had moderate calcification and moderate tortuosity.There were no damages to the device prior to patient use.The device was stored and prepped per the instructions for use (ifu).There was no difficulty delivering the device to the lesion.The delivery system was withdrawn from the patient and the procedure was ended.The device will be returned for evaluation.

Event Description

As reported, after releasing the stent of a 6mm x 80mm smart 120cm vascular self-expanding stent (ses) delivery system, the stent curled up together.When releasing the stent, the knob did not respond and the lever was directly puled to release the stent; however, the stent curled up.The delivery system was then stuck on the unknown guidewire and could not be withdrawn.After several hard attempts, the delivery system was eventually removed.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosed, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) which had moderate calcification and moderate tortuosity.There were no damages to the device prior to patient use.The device was stored and prepped per the instructions for use (ifu).There was no difficulty delivering the device to the lesion.The delivery system was withdrawn from the patient and the procedure was ended.The device will be returned for evaluation.Addendum: the product evaluation revealed the smart ses delivery system was returned separated.

Manufacturer Narrative

Complaint conclusion: after releasing the stent of a 6mm x 80mm smart 120cm vascular self-expanding stent (ses) delivery system, the stent curled up together.When releasing the stent, the knob did not respond and the lever was directly puled to release the stent; however, the stent curled up.The delivery system was then stuck on the unknown guidewire and could not be withdrawn.After several hard attempts, the delivery system was eventually removed.This was during a procedure to treat a 70% stenosed, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) which had moderate calcification and moderate tortuosity.There were no damages to the device prior to patient use.The device was stored and prepped per the instructions for use (ifu).There was no difficulty delivering the device to the lesion.The delivery system was withdrawn from the patient and the procedure was ended.There was no reported injury to the patient.The device was returned for analysis.A non-sterile unit of product ¿pkg assy 6x080 smart vas120cm¿ was received coiled inside of a clear plastic bag.The part was unpacked to perform the evaluation.The stent of the unit was deployed and not returned.In addition, the outer member assay was found separated at 124 cm from the distal tip.No other damages or anomalies were observed at the inspected device.Dimensional analysis was performed to verify the correct od on the profile of the stent.Dimensional analysis results were found within specification.Functional analysis could not be performed due to the returned condition of the device.The separation area was observed under the vision system to magnify the damage.Results showed that the edges on the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.A product history record (phr) review of lot 18018927 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent- incomplete expansion¿ was not confirmed since the stent was not returned for analysis.The reported ¿stent delivery system (sds) - withdrawal difficulty¿ was not confirmed since no functional test could be performed due to the device returned condition.Dimensional analysis of the od of the outer member assay was found within specification.In addition, the reported stent delivery system(sds) -separated was confirmed since the outer sheath assay was found separated, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.According to the instructions for use (ifu) ¿system handling ¿ precautions.Do not use if it appears to be damaged.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review, nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART CONTROL
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 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: 17041491
• MDR Text Key: 316406588
• Report Number: 9616099-2023-06510
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023587
• UDI-Public: (01)20705032023587(17)230331(10)18018927
• 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: 09/22/2023

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 Expiration Date: 03/31/2023
• Device Catalogue Number: C06080MV
• Device Lot Number: 18018927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 67 KG