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

Catalog Number C08060MV

Device Problem Fracture (1260)

Patient Problem Swelling/ Edema (4577)

Event Date 09/02/2023

Event Type  Injury  

Event Description

As reported, a 120cm 8 x 80mm smart vascular stent system was found fractured and the patient presented with abdominal distension and fever several months after implantation of the stent.The patient had originally undergone percutaneous hepatic perforation biliary stenting.The stent was implanted under digital subtraction angiography (dsa) guidance, and the stent was opened completely and positioned accurately.An 8f biliary drain was placed at the proximal end of the stent, and the drainage was smooth.After "fixation", the patient was sent back to the ward and was discharged with improvement.Months later, the patient was hospitalized for "abdominal distension with fever for 2 days", and a chest ct revealed a fractured nickel-titanium stent.It was difficult to remove the stent surgically.The remained in the patient's body.The cause of the fracture was unknown.The combination of biliary obstruction and infection is clear.The patient was treated with anti-infection, hepatoprotective, choleretic regimens, as well as rehydration measures.The patient's vitals have been closely monitored.This has been an isolated case.The surgery was routine.The surgeon was a skilled person.The patient had no falls or impacts.The device was not returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: a 120cm 8 x 80mm smart vascular stent system was found fractured and the patient presented with abdominal distension and fever several months after implantation of the stent.The patient had originally undergone percutaneous hepatic perforation biliary stenting.The stent was implanted under digital subtraction angiography (dsa) guidance, and the stent was opened completely and positioned accurately.An 8f biliary drain was placed at the proximal end of the stent, and the drainage was smooth.After "fixation", the patient was sent back to the ward and was discharged with improvement.Months later, the patient was hospitalized for "abdominal distension with fever for 2 days", and a chest ct revealed a fractured nickel-titanium stent.It was difficult to remove the stent surgically.The remained in the patient's body.The cause of the fracture was unknown.The combination of biliary obstruction and infection is clear.The patient was treated with anti-infection, hepatoprotective, choleretic regimens, as well as rehydration measures.The patient's vitals have been closely monitored.This has been an isolated case.The surgery was routine.The surgeon was a skilled person.The patient had no falls or impacts.Without the return of the device for analysis and based on the information provided, the reported ¿stent- fractured¿ could not be confirmed and the exact root cause could not be determined.According to the instructions for use ¿care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.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.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ stent fractures are a well-known potential complication of this type of procedure and are listed in the ifu as such.Fracture of self-expanding stents occurs in approximately 5% of the cases.Stenting in chronic occlusion represents an increased risk factor for fracture.The reported fever and swelling occurred several months after implantation of the stent.No corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US CORP.; 14021 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: 18084978
• MDR Text Key: 327540972
• Report Number: 9616099-2023-06626
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: C08060MV
• Device Lot Number: 18119908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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
• Patient Outcome(s): Life Threatening