MAUDE Adverse Event Report: CORDIS US. CORP SMART FLEX; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number SF06150MV

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 340901 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.

Event Description

As reported, the 6x150 smart flex stent was positioned in the afs, and could not fully deployed.After approx.50 % of release, the wheel of the handle was too slacky and stent could not be fully deployed.The doctor was able to remove the stent and used another smart flex that worked fine.There was no reported injury to the patient.The device will be returned for evaluation.

Event Description

As reported, the 6x150 smart flex stent was positioned in the superficial femoral artery (sfa), and could not fully deployed.After approximately 50 % of stent was released, the wheel of the handle was too slacky and stent could not be fully deployed.The doctor was able to remove/recapture the stent through an unknown 6f long introducer and used another smart flex that worked fine.The additional stent that was used did fully expand with good wall apposition.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was inspected and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.There was no damage noted to the wheel on the handle prior to use.The stent was still constrained in the outer member/ sheath after removal from the tray.The target lesion diameter was measured to be approximately 5.5mm.The vessel did have moderate tortuosity.The sds system was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user did hold the handle of the smart device flat and straight outside the patient.Unusual force was not applied during stent deployment.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the 6x150 smart flex stent was positioned in the superficial femoral artery (sfa), and could not fully deployed.After approximately 50 % of stent was released, the wheel of the handle was too slacky and stent could not be fully deployed.The doctor was able to remove/recapture the stent through an unknown 6f long introducer and used another smart flex that worked fine.The additional stent that was used did fully expand with good wall apposition.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was inspected and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.There was no damage noted to the wheel on the handle prior to use.The stent was still constrained in the outer member/ sheath after removal from the tray.The target lesion diameter was measured to be approximately 5.5mm.The vessel did have moderate tortuosity.The sds system was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user did hold the handle of the smart device flat and straight outside the patient.Unusual force was not applied during stent deployment.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the 6x150 smart flex stent was positioned in the superficial femoral artery (sfa) and could not fully deployed.After approximately 50 % of stent was released, the wheel of the handle was too slacky and stent could not be fully deployed.The doctor was able to remove/recapture the stent through an unknown 6f long introducer and used another smart flex that worked fine.The additional stent that was used did fully expand with good wall apposition.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was inspected and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.There was no damage noted to the wheel on the handle prior to use.The stent was still constrained in the outer member/ sheath after removal from the tray.The target lesion diameter was measured to be approximately 5.5mm.The vessel did have moderate tortuosity.The sds system was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user did hold the handle of the smart device flat and straight outside the patient.Unusual force was not applied during stent deployment.The device was returned for analysis.A non-sterile ¿smart flex 6x150 vas, 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 observing a kink detected 110cm away from the distal tip along with a complete separation of the proximal portion of the hypotube and the shaft.The stent was mounted on the distal portion of the unit; nevertheless, it was fully deployed.The device deployment mechanism was found to have been triggered which fully deployed the stent; therefore, the functional evaluation could not be performed.A product history record (phr) review of lot 340901 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¿ and subsequent findings of ¿stent delivery system (sds) separated¿ were confirmed during device analysis.However, the exact cause cannot be determined.Functional evaluation could not be performed due to the condition of the returned device as received.Based on the information available for review it is like handling and procedural factors contributed to the events reported by the customer.Additionally, rough shipping/handling conditions may also have had an impact on the subsequent findings as there was no mention of a device separation in the event reported and the stent was able to be recaptured the through an unknown 6f long introducer.According to the instructions for use, which is not intended as a mitigation, ¿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.Prepare stent delivery system: open the outer box to reveal the pouch containing the stent and delivery catheter.After careful inspection of the pouch, looking for damage to the sterile barrier, carefully peel open the outer pouch and extract the inner pouch.Carefully peel open the inner pouch and remove the backerboard with carrier tube which holds the stent delivery system.Warning: do not use if pouch is opened or damaged.Set the backerboard with carrier tube on a flat surface.Remove the stent/delivery system from the carrier tube.Examine the device for damage.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.If the distal tip (8) is not seated in the outer sheath (1), loosen the tuohy borst valve (5) on the handle (3) and retract the pusher tube (2) such that the distal tip (8) will seat in the outer sheath (1).Tighten the tuohy borst valve by rotating the valve hub clockwise.Check to ensure that the touhy borst valve (5) on the handle is tightened on the pusher tube (2).Use a 1-3 cc syringe to flush the outer sheath (1) with sterile heparinized saline through the female luer (4) on the handle.Flush until only a few drops of saline exit the distal end of the outer sheath.Complete system flushing may require 2-3 flushings with a 1cc syringe.Warning: if the outer sheath (1) cannot be flushed do not use the device.Use a 3-10 cc syringe to flush the inner lumen of the guidewire tube with sterile heparinized saline through the proximal luer hub (6) attached to the pusher tube (2), until saline flows out of the guidewire lumen at the distal tip.Warning: if the inner lumen of the guidewire tube (7) cannot be flushed do not use the device.Introduce the stent delivery system: 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.Under fluoroscopic guidance, position the distal stent markers (10) distal to the target lesion and proximal placement marker (12) proximal to the target lesion.Straighten the proximal part of the delivery system as much as possible and keep the handle in a stable position.The tuohy borst valve (5) on the handle (3) must be loosened to allow free movement of the pusher tube (2).¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, g6 additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, the 6x150 smart flex stent was positioned in the superficial femoral artery (sfa), and could not fully deployed.After approximately 50 % of stent was released, the wheel of the handle was too slacky and stent could not be fully deployed.The doctor was able to remove/recapture the stent through an unknown 6f long introducer and used another smart flex that worked fine.The additional stent that was used did fully expand with good wall apposition.There was no reported injury to the patient.The product was stored and handled per the instructions for use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was inspected and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.There was no damage noted to the wheel on the handle prior to use.The stent was still constrained in the outer member/ sheath after removal from the tray.The target lesion diameter was measured to be approximately 5.5mm.The vessel did have moderate tortuosity.The sds system was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user did hold the handle of the smart device flat and straight outside the patient.Unusual force was not applied during stent deployment.The device will be returned for evaluation.

• Brand Name: SMART FLEX
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33314
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 15 christopher way; eatontown, new jersey 07724 ; 7863138372
• MDR Report Key: 18721447
• MDR Text Key: 336635000
• Report Number: 3005089785-2024-00006
• Device Sequence Number: 1
• Product Code: FGE
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SF06150MV
• Device Lot Number: 340901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• 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: SMART FLEX STENT