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

Catalog Number PC0840XCE

Device Problems Crack (1135); Peeled/Delaminated (1454)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

As reported, the delivery rod of the 8mm x 40mm precise pro rx us carotid stent system was fractured.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The intended lesion was the carotid artery.There was no calcification at the target site; however, there was severe tortuosity.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The total length of the stented segment was 40mm.One stent was placed.The stents did not overlap.A cordis pc stent was used.The stent was implanted in an actively moving segment of the artery.Intravascular ultrasound (ivus) was not done after the initial stent placement.The fracture of the stent system was confirmed after removal from the body and observation.The fractured delivery rod was not completely separated.No further stents were implanted at this site.The device will be returned for evaluation.

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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: complaint conclusion: as reported, the delivery rod of the 8mm x 40mm precise pro rx us carotid stent system was fractured.There were no reports of patient injury.The device was stored and prepped in accordance with the instructions for use (ifu).The intended lesion was the carotid artery.There was no calcification at the target site; however, there was severe tortuosity.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The total length of the stented segment was 40mm.One stent was placed.The stents did not overlap.A cordis pc stent was used.The stent was implanted in an actively moving segment of the artery.Intravascular ultrasound (ivus) was not done after the initial stent placement.The fracture of the stent system was confirmed after removal from the body and observation.The fractured delivery rod was not completely separated.No further stents were implanted at this site.The device was returned for evaluation.A non-sterile ¿precise pro rx us carotid syst¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing a separation was present in the distal portion of the device.The stent was still mounted in the manufacturing position concluding there was no attempt to deploy the stent and no successful completion of the full deployment mechanism.A functional analysis could not be performed due to the device conditions as received.A microscopic analysis was completed in the affected portion.During this analysis, elongations and plastic deformations were observed in the separated borders of the affected area.There is evidence that an overloading tensile strength exposure that may have resulted in the separation observed.Additionally, scratch marks were observed near one of the separated borders.These types of marks may be considered evidence of a possible interaction that the surface experienced with sharp edged materials.The reported ¿stent delivery system (sds) - cracked¿ was not confirmed; subsequent findings of ¿inner shaft ¿ exposed braidwire/corewire¿ was confirmed via analysis of the returned device.However, the exact cause of the exposed inner shaft could not be determined.Microscopic analysis presented evidence of elongations and plastic deformations along with a separation of the distal portion of the device exposing the 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.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 OUS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US CORP.; 14021 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: 18649987
• MDR Text Key: 334643553
• Report Number: 9616099-2024-00043
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18201643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female