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

Catalog Number PC0840RXC

Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the delivery shaft of an 8mm x 40mm precise pro carotid self-expanding stent (ses) delivery system fractured while inside of the patient.The device still remained in one piece despite the fracture and was able to be removed easily from the patient.A new 8mm x 30mm precise pro ses was used to complete the procedure.There were no reported injuries to the patient.This was during a stroke/carotid procedure.There was no calcification at the lesion; however, there was severe tortuosity.The device will be returned for evaluation.

Event Description

As reported, the delivery shaft of an 8mm x 40mm precise pro carotid self-expanding stent (ses) delivery system fractured while inside of the patient.The device still remained in one piece despite the fracture and was able to be removed easily from the patient.A new 8mm x 30mm precise pro ses was used to complete the procedure.There were no reported injuries to the patient.This was during a stroke/carotid procedure.There was no calcification at the lesion; however, there was severe tortuosity.The device will be returned for evaluation.Addendum: product evaluation revealed that the inner shaft braidwire of the precise pro sds is exposed.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: 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

Complaint conclusion: as reported, the delivery shaft of an 8mm x 40mm precise pro carotid self-expanding stent (ses) delivery system fractured while inside of the patient.The device still remained in one piece despite the fracture and was able to be removed easily from the patient.A new 8mm x 30mm precise pro ses was used to complete the procedure.There were no reported injuries to the patient.This was during a stroke/carotid procedure.There was no calcification at the lesion; however, there was severe tortuosity.The device was returned for analysis.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 that the received device was not attempted to deploy the stent or successfully completed the full deployment mechanism.A functional analysis could not be done due to the device conditions received.A microscopical analysis was completed in the affected portion.During this analysis, elongations and plastic deformations could be observed in the separation borders of the affected area that evidenced an overloading of tensile strength exposure that may have resulted in the separation observed.The reported ¿stent delivery system (sds) - cracked¿ was not confirmed; 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.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.Additionally, rough 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d9, g3, g6, h1, h2, h3, h6, and h10 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.

• 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: 18517082
• MDR Text Key: 333011777
• Report Number: 9616099-2024-00014
• 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,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 18233365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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: 8MM X 30MM PRECISE PRO SES; EXCELSIOR SL-10; SINCRO STANDARD
• Patient Age: 58 YR
• Patient Sex: Male