MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X40; STENT, ILIAC

Model Number C07040SL

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the locking pin on a smart control stent (iliac 7x40) was found to be released when the device¿s pouch was opened.The device was replaced with a non-cordis stent of the same size to continue the procedure.Initially, an ipsilateral approach was made to the lesion in the superficial femoral artery using a non-cordis sheath.The lesion was described as a chronic total occlusion.A post-dilation was performed and the procedure was completed.There was no patient injury reported.The device was not clinically used and has been discarded in the hospital by mistake, so will not be returned for analysis.

Manufacturer Narrative

Prior to use for a superficial femoral artery stenting procedure, the locking pin on a smart control stent (iliac 7x40) was found to be released when the device¿s pouch was opened.The device was replaced with a non-cordis stent of the same size to continue the procedure.There was no patient injury reported.Initially, an ipsilateral approach was made to the lesion in the superficial femoral artery using a non-cordis sheath.The lesion was described as a chronic total occlusion.A post-dilation was performed, and the procedure was completed.No other information was reported.The device was not returned for analysis.A product history record (phr) review of lot 17731096 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿locking pin (smart control only) loose - in package¿ could not be confirmed since the device was not returned for analysis.The exact cause of the reported event could not be determined.Storage and handling factors may have contributed to the event.As stated in the instructions for use, which is not intended as a mitigation, ¿open the box to reveal the pouch containing the stent and delivery system.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.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.¿ the available information nor the phr review suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 7X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8000762
• MDR Text Key: 126238207
• Report Number: 9616099-2018-02458
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: C07040SL
• Device Catalogue Number: C07040SL
• Device Lot Number: 17731096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F TERUMO SHEATH, LIFESTENT - C.R. BARD