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

Catalog Number PC0640RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

As reported, the 6x40 precise pro could not be used because the blood vessels were tortuous and could not reach the lesion.There was no reported injury to the patient.The precise stent was used for a carotid artery stenting (cas) case.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained.The product evaluation confirmed the device was partially deployed.

Manufacturer Narrative

Section e1: ph # (b)(6).As reported, the 6x40 precise pro could not be used because the blood vessels were tortuous and could not reach the lesion.There was no reported injury to the patient.The precise stent was used for a carotid artery stenting (cas) case.Additional information was requested; however, the information was not obtained.The device was returned for analysis.A non-sterile ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on a metallic tray to be inspected.A thorough inspection was performed observing that the unit does not presents damages.The device is partially deployed.The hemostasis valve was returned disassembled.No other outstanding details were noticed.Dimensional analysis was performed to verify the correct od of the stent crossing profile.Measurements were taken at three different places and results were found within specification.The usable length was measured and found within specification.Functional testing related to the failure to tracking difficulty malfunction was not performed due to the nature of the complaint; the reported malfunction is not possible to reproduce in a laboratory environment.The functionality of the device was performed to determine if the stent can be deployed as expected.The hemostasis valve was reassembled and unlocked.The stent deployment was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.The push rod traveled toward the distal tip as expected and the stent was deployed.The stent expanded normally presenting no damages or anomalies.The reported ¿stent delivery system (sds) tracking difficulty¿ could not be confirmed due to the nature of the complaint as this cannot be replicated in the lab.Additionally, the od was measured along with the usable length, and both found within specification.Subsequent findings of ¿stent delivery system (sds) partial deployment¿ was observed on the returned device.However, the exact cause of the issue experienced by the customer could not be determined.There was no mention of partial stent deployment in the event description provided.Functionality of the deployment mechanism was tested with no difficulties noted.Additionally, no kinks or other damages were noted to the device upon analysis.Therefore, based on the information available for review it is likely patient/vessel characteristics contributed to the event reported as the vessels were noted to be tortuous, and the sds could not reach the lesion.Subsequently, product analysis revealed a partial deployment of the stent, and it is difficult to determine what factors may have contributed to the analysis findings.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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand (often referred to as the ¿pin-and-pull¿ method).Post-deployment stent dilatation: while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.(do not remove guidewire.) using fluoroscopy, visualize the stent to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation (standard pta technique) can be performed.¿ 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18981796
• MDR Text Key: 339297674
• Report Number: 9616099-2024-00088
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030047
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: PC0640RXC
• Device Lot Number: 18100354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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