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

Model Number C07060ML

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18186749 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.This device is available for analysis but has not yet been received.

Event Description

As reported, a 7mm x 60mm smart control stent failed to deliver out of the sheath.The stent somehow started to deploy once it reached the tip of the sheath.It was than stuck to the sheath.We had to pull the sheath and start again.The case was completed with another smart control.The device was thrown away.There was no reported injury to the patient.The user was experienced in using the device.There were no adverse events after the back-up stent was used.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is 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.There was no difficulty encountered flushing the sds.The lesion was measured to be 6mm in diameter.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The sds did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The smart control locking pin was in place during advancement towards the lesion.The device will be returned for evaluation.

Event Description

As reported, a 7mm x 60mm smart control stent failed to deliver out of the sheath.The stent somehow started to deploy once it reached the tip of the sheath.It was than stuck to the sheath.We had to pull the sheath and start again.The case was completed with another smart control.There was no reported injury to the patient.The user was experienced in using the device.There were no adverse events after the back-up stent was used.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is 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.There was no difficulty encountered flushing the sds.The lesion was measured to be 6mm in diameter.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The sds did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The smart control locking pin was in place during advancement towards the lesion.The device will not be returned for evaluation as it was discarded.No product was received for analysis, instead three pictures related to the reported failure were attached.Picture #1 shows the bar code of the smart control, the following data can be read, lot, catalog, use by date.Picture#2 shows the distal section of the smart control device.The tip is damaged, and the stent shows the strut uplifted.Picture #3 shows the smart control unit, holding by the physician, the unit is inserted into an unknown sheath.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.As reported, a 7mm x 60mm smart control stent failed to deliver out of the sheath.The stent somehow started to deploy once it reached the tip of the sheath.It was than stuck to the sheath.We had to pull the sheath and start again.The case was completed with another smart control.The user was experienced in using the device.There were no adverse events after the back-up stent was used.The product was stored and handled according to the ifu.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is 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.There was no difficulty encountered flushing the sds.The lesion was measured to be 6mm in diameter.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The sds did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.Unusual force was not used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The smart control locking pin was in place during advancement towards the lesion.No product was received for analysis, instead three pictures related to the reported failure were attached.Picture #1 shows the bar code of the smart control, the following data can be read, lot, catalog, use by date.Picture#2 shows the distal section of the smart control device.The tip is damaged, and the stent shows the strut uplifted.Picture #3 shows the smart control unit, holding by the physician, the unit is inserted into an unknown sheath.No product was received for analysis, instead three pictures related to the reported failure were attached by the customer at the complaint (b)(4).The picture #1 shows the bar code of the smart control, the following data can be read: lot# 18186749, catalogue# c07060ml and use by date# 25-01-31.The picture#2 shows the distal section of the smart control device.The tip is damaged, and the stent shows the strut uplifted.The picture #3 shows the smart control unit, holding by the physician, the unit is inserted into an unknown sheath.No other anomalies of the product can be noticed at the attached pictures.The reported ¿withdrawal difficulty & sds-deployment difficulty¿ could not be confirmed as we cannot confirm or deny the failures via an image without a proper device evaluation.The root cause of the failures reported by the customer could not conclusively determined as part of the picture evaluation; therefore, it is not possible to establish whether it is related to the manufacturing process of the product.According to the instructions for use (ifu) ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.For stent deployment, the locking pin must be removed.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.¿ neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL ILIAC
• 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: 16876477
• MDR Text Key: 314985171
• Report Number: 9616099-2023-06483
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023839
• UDI-Public: (01)20705032023839(17)250131(10)18186749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020036
• 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
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C07060ML
• Device Catalogue Number: C07060ML
• Device Lot Number: 18186749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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