MAUDE Adverse Event Report: CORDIS US. CORP SMART CONTROL, ILIAC 8X40; STENT, ILIAC

Model Number C08040SL

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18103600 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.

Event Description

As reported, the 8x40 smart control stent was inserted into the sheath to be used for the proximal superficial femoral artery.A contralateral approach was made with a 45cm non-cordis guiding sheath.The physician noticed that the stent was slightly deployed flare from the tip when the complaint device came out of the sheath.It was noted that approximately 5mm of the stent was deployed.The complaint device was removed without implant, but the stent strut got caught on the y-connector of the concomitant sheath.The stent was deployed outside the body in such a way that the stent was entangled with the y-connector from the delivery system.Considering the possibility that the stent was slightly deployed due to calcification in the iliac, the physician changed to an ipsilateral approach.The sheath was replaced with a new 23cm non-cordis sheath and a smart stent (8*30) was used for the superficial femoral artery and the procedure completed.The second stent was placed with and was well expanded and in good position.There was no reported injury to the patient.There was no lesion at the iliac artery.The product was stored and handled according to the instruction for use (ifu).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 according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath after removed from the tray.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock or while flushing the stent delivery system (sds).The intended lesion was measured to be 7mm in diameter.The lesion has severe calcification with mild tortuosity.The smart control locking pin was in place during advancement towards the lesion.The locking pin was not released, and the physician did not touch the control handle lever or the dial.The handle was held flat and straight outside the patient, like the ifu instructs.Unusual force was not applied during advancement.The device will be returned for evaluation.

Event Description

As reported, the 8x40 smart control stent was inserted into the sheath to be used for the proximal superficial femoral artery.A contralateral approach was made with a 45cm non-cordis guiding sheath.The physician noticed that the stent was slightly deployed flare from the tip when the complaint device came out of the sheath.It was noted that approximately 5mm of the stent was deployed.The complaint device was removed without implant, but the stent strut got caught on the y-connector of the concomitant sheath.The stent was deployed outside the body in such a way that the stent was entangled with the y-connector from the delivery system.Considering the possibility that the stent was slightly deployed due to calcification in the iliac, the physician changed to an ipsilateral approach.The sheath was replaced with a new 23cm non-cordis sheath and a smart stent (8*30) was used for the superficial femoral artery and the procedure completed.The second stent was placed with and was well expanded and in good position.There was no reported injury to the patient.There was no lesion at the iliac artery.The product was stored and handled according to the instruction for use (ifu).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 according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath after removed from the tray.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock or while flushing the stent delivery system (sds).The intended lesion was measured to be 7mm in diameter.The lesion has severe calcification with mild tortuosity.The smart control locking pin was in place during advancement towards the lesion.The locking pin was not released, and the physician did not touch the control handle lever or the dial.The handle was held flat and straight outside the patient, like the ifu instructs.Unusual force was not applied during advancement.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d9, g3, h1, h2, h3 and h6 the 8x40 smart control stent was inserted into the sheath to be used for the proximal superficial femoral artery.A contralateral approach was made with a 45cm non-cordis guiding sheath.The physician noticed that the stent was slightly deployed flare from the tip when the complaint device came out of the sheath.It was noted that approximately 5mm of the stent was deployed.The complaint device was removed without implant, but the stent strut got caught on the y-connector of the concomitant sheath.The stent was deployed outside the body in such a way that the stent was entangled with the y-connector from the delivery system.Considering the possibility that the stent was slightly deployed due to calcification in the iliac, the physician changed to an ipsilateral approach.The sheath was replaced with a new 23cm non-cordis sheath and a smart stent (8*30) was used for the superficial femoral artery and the procedure completed.The second stent was placed with and was well expanded and in good position.There was no lesion at the iliac artery.The product was stored and handled according to the instruction for use (ifu).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 according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath after removed from the tray.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock or while flushing the stent delivery system (sds).The intended lesion was measured to be 7mm in diameter.The lesion has severe calcification with mild tortuosity.The smart control locking pin was in place during advancement towards the lesion.The locking pin was not released, and the physician did not touch the control handle lever or the dial.The handle was held flat and straight outside the patient, like the ifu instructs.Unusual force was not applied during advancement.There was no reported injury to the patient.The device was received for analysis.A non-sterile unit ¿smart control, iliac 8x40¿ was received coiled inside a clear plastic bag.The unit was unpacked to proceed with the evaluation.The unit presents a kink with torn outer sheath located approximately at 77.7 cm from the distal tip.Also, a second kink was noticed located approximately at 85 cm from the distal tip.The locking pin es fixed into the handle.No other outstanding details were noticed.Functional analysis was not performed due to the unit was returned fully deployed.The kinked area was inspected using a vision system to obtain a magnified image observing that the torn area of the unit presented evidence of elongations, wires fractured/separated and plastic deformations.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.No other anomalies were observed.A product history record (phr) review of lot 18103600 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)-ses ~ deployment difficulty - premature/in patient - during withdrawal¿ and ¿stent delivery system (sds)-ses ~ deployment difficulty - premature/in patient¿ was not confirmed since the unit was returned with the stent fully deployed.However, the unit presented two kinks and a torn/frayed condition on the outer sheath.The exact cause of this damages could not be determined during the analysis.Procedural factors and handling process (material tensile overload) may have contributed to these damages.However, it is probable that the user¿s interaction with the device led to the reported events.As during the investigation conducted, the user stated that ¿the lesion has severe calcification with mild tortuosity.¿ 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 evaluation suggests that the reported events are related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 8X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16335127
• MDR Text Key: 309172188
• Report Number: 9616099-2023-06247
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024119
• UDI-Public: (01)20705032024119(17)240331(10)18103600
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: C08040SL
• Device Catalogue Number: C08040SL
• Device Lot Number: 18103600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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: 23 PARENT SHEATH; 45 PARENT SHEATH; SMART STENT (8*30)