MAUDE Adverse Event Report: CORDIS US CORP. SMART FLEX; CATHETER, PERCUTANEOUS

Catalog Number SF06150MB

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 04/05/2023

Event Type  malfunction  

Event Description

As reported, a 6mm x 150 mm 120 cm biliary smart flex ses (self-expanding stent) delivery system did not fully deploy.The pull and pin delivery system were performed until the last 20-30mm of the proximal end of the stent, and it would not deploy further.The stent and system were removed from the patient.There was no reported patient injury.Slight resistance/friction was felt during insertion of the device.The stent delivery system passed through acute bends.The delivery of the sds to the lesion was contralateral.There was a slight difficulty encountered while advancing/tracking the sds towards the lesion.The intended procedure was reported to be a superficial femoral artery (sfa) intervention.The target lesion was the sfa with no calcification.Vessel tortuosity was described as "tough" to get up and over the bifurcation.The device was stored, handled, and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized 1-2 mm larger than the target area.No unusual force was used at any time during the procedure.The area was pre-dilated prior to stent implantation.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 review of the manufacturing documentation associated with lot 308348 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A 6mm x 150 mm 120 cm biliary smart flex ses (self-expanding stent) delivery system did not fully deploy.The pull and pin delivery system were performed until the last 20-30mm of the proximal end of the stent, and it would not deploy further.The stent and system were removed from the patient.Slight resistance/friction was felt during insertion of the device.The stent delivery system passed through acute bends.The delivery of the sds to the lesion was contralateral.There was a slight difficulty encountered while advancing/tracking the sds towards the lesion.The intended procedure was reported to be a superficial femoral artery (sfa) intervention.The target lesion was the sfa with no calcification.Vessel tortuosity was described as "tough" to get up and over the bifurcation.The device was stored, handled, and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized 1-2 mm larger than the target area.No unusual force was used at any time during the procedure.The area was pre-dilated prior to stent implantation.There was no reported patient injury.The device was returned for analysis.One non-sterile unit of product ¿smart flex 6x150 bil, 120cm¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected, and it was noticed that the stent was fully deployed and returned for analysis.The hemostasis valve was closed, and an outer sheath separation was observed located approximately at 134.5 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was not performed due to the observed separation in the outer sheath.Functional test was not performed due to the separation condition on the outer sheath and since to the unit was returned fully deployed.The separated area was analyzed using a 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 308348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-deployment difficulty - partial deployment¿ was not confirmed since the stent was received fully deployed.However, the returned unit presents a separated condition.The exact cause of the observed separated condition could not be determined.It is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.Procedural factors and handling process such as the user¿s interaction with the device during use may have contributed to the reported event.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.¿ neither the phr review nor the product analysis suggests that the reported event 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 FLEX
• Type of Device: CATHETER, PERCUTANEOUS
• 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 ; 15 christopher way; eatontown, new jersey 07724 ; 7863138372
• MDR Report Key: 16835808
• MDR Text Key: 314411485
• Report Number: 3005089785-2023-00121
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032066034
• UDI-Public: (01)20705032066034(17)241101(10)308348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SF06150MB
• Device Lot Number: 308348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: White