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

Catalog Number SF06040MV

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

As reported, a smart flex 6x40 120cm vascular ses (self-expanding stent) deployed partially while being used in a percutaneous transluminal angioplasty (pta) case; however, it did not fully expand, or function properly.Due to the highly tortuosity of the vessel, the user mentioned that additional force was required during insertion of the device.This resulted in some resistance and friction, as well as some difficulty while advancing/tracking the sds towards the lesion.There was no reported patient injury.The target lesion was reported to be the superficial femoral artery (sfa).There was severe lesion calcification.The device was stored and prepped according to 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 constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized larger than the target area.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.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 product history record (phr) review of lot 298047 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.

Manufacturer Narrative

A smart flex 6x40 120cm vascular ses (self-expanding stent) deployed partially while being used in a percutaneous transluminal angioplasty (pta) case; however, it did not fully expand, or function properly.Due to the highly tortuosity of the vessel, the user mentioned that additional force was required during insertion of the device.This resulted in some resistance and friction, as well as some difficulty while advancing/tracking the sds towards the lesion.The target lesion was reported to be the superficial femoral artery (sfa).There was severe lesion calcification.The device was stored and prepped according to 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 constrained within the outer sheath when it was removed from the tray.The diameter of the unconstrained stent was sized larger than the target area.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.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 6x40 vas, 120cm¿ was received coiled inside of a clear plastic bag.The device was unpacked and was laid flat on a tray to proceed with the product evaluation.The unit was thoroughly inspected observing that the hypotube presented a kinked condition at 4.5 cm from the distal end, stent is partial, and the hemostasis valve is open.No other damages or anomalies were observed on the returned device.Functional analysis was performed to determine if the stent could be deployed as expected.The hemostasis valve was unlocked of the stent delivery system.The stent deployment functionally test was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.However, the push rod did not travel towards the distal tip as expected due to the severed damaged observed on the device.A product history record (phr) review of lot 298047 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 confirmed since the stent was not able to be fully deployed due to the severe damage of the device.Stent delivery system (sds)-tracking difficulty was not confirmed.Since due to the nature of the complaint, it is not possible to determine what may have caused the reported issue.Procedural factors and handling process may have contributed to the reported events.These include and are not limited to the user¿s interaction with the device during use as well as vessel characteristics (severe lesion calcification).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 events 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: 17193489
• MDR Text Key: 317955330
• Report Number: 3005089785-2023-00127
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032066676
• UDI-Public: (01)20705032066676(17)240511(10)298047
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SF06040MV
• Device Lot Number: 298047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• 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
• Treatment: N/A.