MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X60ML; STENT, ILIAC

Model Number C10060ML

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

An unknown guidewire crossed the lesion and the smart control 10mm x 60mm self-expanding stent (ses) was delivered to the lesion.However, it was difficult to reach the lesion.Therefore, the smart stent was removed, and the distal end tip was noted to be frayed.It was replaced with a new smart stent but with a different size.The lesion was the iliac artery.The device was used in an endovascular therapy (evt) with a contralateral approach.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The guidewire port was flushed as outlined in the ifu.The lesion had a moderate calcification, little vessel tortuosity and had a 90 % stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).The self-expanding stent (ses) did not pass through any acute bends and did not pass through a previously placed stent.The stent was still constrained within the outer member/sheath when removed from the tray.The smart control locking pin was in place during advancement towards the lesion.Other devices used with the product were not kinked or bent at any time and were not re sterilized.Additional procedural details were requested but are unknown.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17783211 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the limited information provided, the reported ¿catheter tip- frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as vessel characteristics (although unknown) may have contributed to the reported event.According to the instructions for use, which are not intended as a mitigation of risk, ¿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.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

The unknown guidewire crossed the lesion and the 10mm x 60mm smart control self-expanding stent (ses) was delivered to the lesion.However, it was difficult to reach the lesion.Therefore, the smart stent was removed, and the distal end tip was noted to be frayed.It was replaced with a new smart stent but with a different size.There was no reported patient injury.The lesion was the iliac artery.The device used in endovascular therapy (evt) with a contralateral approach.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The guidewire port was flushed as outlined in the ifu.The lesion had a moderate calcification, little vessel tortuosity and had a 90 % stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).The self-expanding stent (ses) did not pass through any acute bends and did not pass through a previously placed stent.The stent was still constrained within the outer member/sheath when removed from the tray.The smart control locking pin was in place during advancement towards the lesion.Other devices used with the product was not kinked or bend at any time and was not resterilized.The device will not be returned for analysis since it was discarded in the hospital.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 10X60ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10026751
• MDR Text Key: 200261077
• Report Number: 9616099-2020-03688
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024638
• UDI-Public: 20705032024638
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: C10060ML
• Device Catalogue Number: C10060ML
• Device Lot Number: 17783211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2020
• Date Device Manufactured: 05/29/2018
• 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