MAUDE Adverse Event Report: CORDIS CORPORATION SMART; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number C07150ML

Device Problems Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454)

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

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, an implant failure occurred due to separation between the catheter of a 120 150, 7 x 150mm smart vascular stent system and the hub.The stent was partially deployed when the separation occurred between the hub and the catheter.After some time and effort, the physician successfully removed the device, but the stent was deployed not in the exact desired location.The procedure was completed after doctor manually pulled the catheter of the device back to release the whole stent.In other words, he brought the separated catheter back to the hub to expose the rest of the sheath.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The separation was observed inside of the patient.The intended lesion was the superficial femoral artery.The target site vessel was moderately calcified, mildly tortuous, 75% stenosed, with no acute angulation, chronic total occlusion or bifurcation.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system (sds) was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user maintained a fixed inner shaft position during deployment.Excess force was applied during deployment of the stent because the catheter was stuck halfway deployed.There was no indication that the stent was prematurely deployed.The device was not attempted to be deployed outside of the body.There was no patient injury during this procedure.The device was not inserted through a stopcock instead of a hemostatic valve.The customer is keeping the device for now; therefore, the device will not be returned for evaluation.

Manufacturer Narrative

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

Event Description

As reported, an implant failure occurred due to separation between the catheter of a 120 150, 7 x 150mm smart vascular stent system and the hub.The stent was partially deployed when the separation occurred between the hub and the catheter.The delivery device separated at three different locations along the delivery shaft.After some time and effort, the physician successfully removed the device, but the stent was deployed not in the exact desired location.This issue caused a significant geographic miss of the stent location in relation to the lesion.The procedure was completed after doctor manually pulled the catheter of the device back to release the whole stent.In other words, he brought the separated catheter back to the hub to expose the rest of the sheath.As a result, the procedure time was prolonged, and there was increased radiation exposure to the patient.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The separation was observed inside of the patient.The intended lesion was the superficial femoral artery.The target site vessel was moderately calcified, mildly tortuous, 75% stenosed, with no acute angulation, chronic total occlusion or bifurcation.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system (sds) was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user maintained a fixed inner shaft position during deployment.Excess force was applied during deployment of the stent because the catheter was stuck halfway deployed.There was no indication that the stent was prematurely deployed.The device was not attempted to be deployed outside of the body.The device was not inserted through a stopcock instead of a hemostatic valve.The customer is keeping the device for now; therefore, the device will not be returned for evaluation.

• Brand Name: SMART
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19199197
• MDR Text Key: 341241955
• Report Number: 9616099-2024-00126
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042969
• 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
• Report Date: 04/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C07150ML
• Device Lot Number: 18254594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: UNKNOWN CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening