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

Catalog Number C07150ML

Device Problems Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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device or packaging prior to use in the patient.The stent delivery system (sds) was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user maintained a fixed inner shaft position during deployment.Excess force was applied during deployment of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.

Manufacturer Narrative

Corrected section health effect - impact code from "1510 - radiation overdose" to "4610 - inadequate/inappropriate treatment or diagnostic exposure".Complaint conclusion: as reported, an implant failure occurred due to separation between the catheter of a smart 120/150, 7 x 150mm 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.The device was not returned for analysis; however, five images were provided for review.A smart device is observed in the images provided.The outer sheath is noted to be separated near the strain relief section.No other anomalies could be noted on the pictures attached.The reported ¿outer sheath ¿ separated¿, ¿outer sheath exposed braidewire/corewire¿ and ¿stent delivery system (sds) separated¿ were confirmed based on the images provided.The outer sheath is noted to be separated and the braidewire/corewire is visible in the images.Additionally, the reported ¿deployment difficulty - inaccurate placement¿ was likely a consequence of the separation of the outer sheath; however, this cannot be confirmed as the device was not returned for analysis and functional testing cannot be performed.Based on the information available for review, it is likely procedural and/or handling factors contributed to the events reported as evidenced by the damages noted in the provided images.It appears the device was induced to events that exceeded its material yield strength prior to the separation noted.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu cautions, ¿when catheters are in the body, they should be manipulated using high quality radiographic equipment.Prior to stent deployment, remove all slack from catheter delivery system (see ¿stent deployment/ procedure¿).Ensure locking pin is still in place.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.Advance the stent delivery system over the guidewire through the sheath introducer to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an appropriate size introducer sheath for the implant procedure to protect vessel and access site.Slack removal advance the stent delivery system past the lesion site.Pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the lesion site.Ensure that the stent delivery system outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.¿ the information available does not suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• 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 ; 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,Followup
• Report Date: 05/24/2024

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 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
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/28/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/24/2024
• 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