MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X120MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number C07120ML

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

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18068558 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was resistance with a 7x120mm smart self-expanding stent (ses) delivery system so it could not cross.The smart ses was removed and checked; the distal end of the tip got frayed.Therefore, it was replaced with a new unknown smart stent.There was no reported patient injury.An unknown balloon catheter was inflated.The device was discarded and will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, after pre-dilation of an iliac artery lesion with an unknown balloon catheter, there was resistance with a 7mm x 120mm smart self-expanding stent (ses) delivery system, and the device could not cross the lesion.The 7mm x 120mm smart ses was removed and fraying of the distal tip was observed.Therefore, it was replaced with a new smart stent of an unknown size which was used without issue.There was no reported patient injury.This was during an endovascular therapy (evt) procedure to treat an iliac artery lesion which had a vessel diameter of 7mm.The device was stored, handed, and prepped per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible, and there was nothing unusual noted about the delivery system prior to use.The stent was still constrained within the outer sheath while removing the delivery system from its tray.There were no difficulties flushing the stopcock or the delivery system itself.A contralateral approach was made from the femoral artery.The delivery system did not pass through any acute bends or previously placed stents, and no unusual force was used during this procedure.The delivery system was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the patient, access vessel characteristics, percentage of stenosis at the target vessel, target vessel characteristics, sheath used for access, and dimensions of smart stent used as a replacement was requested but was not provided.The device was discarded and will not be returned for evaluation.The device was not returned for analysis.A product history record (phr) review of lot 18068558 revealed no anomalies or non-conformances 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 information provided, the reported ¿stent delivery system (sds)-ses~ failure to cross¿ and ¿catheter tip~ frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics (although unknown) and or the user¿s interaction with the device may have led to the reported events.According to the instructions for use ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent¿.Neither the phr review nor the information available suggests that the reported events are related to the design or manufacturing process of the device.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, after pre-dilation of an iliac artery lesion with an unknown balloon catheter, there was resistance with a 7mm x 120mm smart self-expanding stent (ses) delivery system, and the device could not cross the lesion.The 7mm x 120mm smart ses was removed and fraying of the distal tip was observed.Therefore, it was replaced with a new smart stent of an unknown size which was used without issue.There was no reported patient injury.This was during an endovascular therapy (evt) procedure to treat an iliac artery lesion which had a vessel diameter of 7mm.The device was stored, handed, and prepped per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible, and there was nothing unusual noted about the delivery system prior to use.The stent was still constrained within the outer sheath while removing the delivery system from its tray.There were no difficulties flushing the stopcock or the delivery system itself.A contralateral approach was made from the femoral artery.The delivery system did not pass through any acute bends or previously placed stents, and no unusual force was used during this procedure.The delivery system was able to be removed easily from the patient and remained in one piece during its removal.Information regarding the patient, access vessel characteristics, percentage of stenosis at the target vessel, target vessel characteristics, sheath used for access, and dimensions of smart stent used as a replacement was requested but was not provided.The device was discarded and will not be returned for evaluation.

• Brand Name: SMART 120 150, SFA - 7X120MM
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 32574
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14336553
• MDR Text Key: 293191359
• Report Number: 9616099-2022-05613
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032063422
• UDI-Public: (01)20705032063422(17)231031(10)18068558
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042969
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: C07120ML
• Device Catalogue Number: C07120ML
• Device Lot Number: 18068558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Date Device Manufactured: 11/12/2021
• 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 BALLOON CATHETER; UNKNOWN SMART STENT