MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX; STENT, CAROTID

Catalog Number PC0540RXC

Device Problems Difficult or Delayed Positioning (1157); Appropriate Term/Code Not Available (3191)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while attempting to deploy the stent on a 5mm x 40mm precise pro carotid self-expanding stent (ses) delivery system, the user heard and felt a ¿snap¿.The stent was minimally deployed but was removed from the patient.A new precise pro ses was used as a replacement.A total of three stents were successfully implanted to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat a left internal carotid artery lesion which had mild calcification and mild tortuosity.The device was inserted into an unknown catheter sheath introducer (csi) prior to attempted deployment.The user maintained a fixed inner shaft position during the attempted deployment.The device was able to be removed easily from the patient and remained in one piece during its removal.The device will be returned for evaluation.

Event Description

As reported, while attempting to deploy the stent on a 5mm x 40mm precise pro carotid self-expanding stent (ses) delivery system, the user heard and felt a ¿snap¿.The stent was minimally deployed but was removed from the patient.A new precise pro ses was used as a replacement.A total of three stents were successfully implanted to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat a left internal carotid artery lesion which had mild calcification and mild tortuosity.The device was inserted into an unknown catheter sheath introducer (csi) prior to attempted deployment.The user maintained a fixed inner shaft position during the attempted deployment.The device was able to be removed easily from the patient and remained in one piece during its removal.The device will be returned for evaluation.Addendum: product evaluation revealed that the inner shaft braidwire on the precise pro sds is exposed.

Manufacturer Narrative

The medical device problem code 3191 was selected due to an inability to select the appropriate code ¿delivery system failure¿.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, while attempting to deploy the stent on a 5mm x 40mm precise pro carotid self-expanding stent (ses) delivery system, the user heard and felt a ¿snap¿.The stent was minimally deployed but was removed from the patient.A new precise pro ses was used as a replacement.A total of three stents were successfully implanted to complete the procedure.There were no reported injuries to the patient.This was during a procedure to treat a left internal carotid artery lesion which had mild calcification and mild tortuosity.The device was inserted into an unknown catheter sheath introducer (csi) prior to attempted deployment.The user maintained a fixed inner shaft position during the attempted deployment.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was returned for evaluation.A non-sterile ¿precise pro rx ous carotid sys¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing the following conditions: the device was fully deployed.The stent was retuned presenting no anomalies or damages and it is properly expanded.The device presents a separated condition that exposed the braidewire located approximately 20.5cm from the distal tip.A kinked condition was observed located approximately 114 and 117cm from the distal tip.The hemostasis valve was returned tightly closed.No other outstanding details were observed.The usable length and outer sheath length along with functional testing could not be performed due to the separated and kinked conditions found.Sem analysis was not required as the damages associated with the separation are visible with the magnification obtained with a vision system.The separated area was revealed an exposed braidewire which presented evidence of elongations on both edges.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the device was induced to a tensile force that exceeded the material yield strength prior to the separation.The reported ¿stent delivery system (sds) deployment difficulty-partial deployment¿ was not confirmed as the stent was received with the device already deployed and partial deployment cannot be assessed; however, subsequent findings of ¿inner shaft ¿ exposed braidewire/corewire¿ was confirmed via analysis of the returned device.However, the exact cause of the exposed inner shaft could not be determined.Vision system analysis presented evidence of elongations on both edges of the exposed inner shaft.Based on the information available for review the device was induced to events that exceeded its material yield strength prior to the separation.It is likely procedural and/or handling factors may have contributed to the event reported.Additionally, shipping/handling conditions may also have had an impact on the event as there was no mention of a complete device separation in the event reported as the product was removed intact from the patient.According to the instructions for use, which is not intended to mitigate risk, ¿extract the stent delivery system from the tray.Examine the device for any damage.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.Flush the guidewire lumen of the stent delivery system with heparinized saline by connecting a 5-cc syringe filled with heparinized saline solution to the stopcock attached to the y connection (9) on the tuohy borst valve (1) to expel air.Ensure that the tuohy borst valve (1) is in the locked position to prevent premature stent deployment.Apply positive pressure to the syringe until saline weeps from the guidewire exit port (16).While covering the guidewire exit port (16) with thumb and forefinger, apply positive pressure to the syringe until saline weeps from the catheter tip (4) and the space between the outer sheath radiopaque marker (11) and the catheter tip (4).Continue to flush to ensure all air is removed from the system, then close the stopcock attached to the y connection (9) on the tuohy borst valve (1).B.Ensure that the tuohy borst valve connecting the inner shaft and outer sheath is locked by rotating the proximal valve end in a clockwise direction to prevent premature stent deployment.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ 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: PRECISE PRO RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 18553904
• MDR Text Key: 333380758
• Report Number: 9616099-2024-00027
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0540RXC
• Device Lot Number: 18223251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: PRECISE STENT; UNKNOWN SHEATH
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 100 KG