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

Catalog Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/08/2023

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, the delivery rod on a 7mm x 40mm precise pro rx stent delivery system was found bent upon opening the package.The stent was found to be deployed partially after being removed from the packaging.The product did not enter the body.The procedure was completed by replacing the complaint device with another pc stent.There were no reports of patient injury.The physician has been trained and has used the device properly in the past.The surgeon tried to retrieve it but failed.There was no difficulty removing the product from the packaging.The device was stored and prepped in accordance with the instructions for use (ifu).The device will be returned for evaluation.Addendum: the device was returned with the stent partially deployed.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported, the delivery rod on a 7mm x 40mm precise pro rx stent delivery system was found bent upon opening the package.The stent was found to be deployed partially after being removed from the packaging.The product did not enter the body.The procedure was completed by replacing the complaint device with another pc stent.There were no reports of patient injury.The physician has been trained and has used the device properly in the past.The surgeon tried to retrieve it but failed.There was no difficulty removing the product from the packaging.The device was stored and prepped in accordance with the instructions for use (ifu).The device was returned for analysis.A non-sterile ¿precise pro rx ous carotid sys¿ 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 that it does not present any damages or anomalies.The device was already deployed before it¿s arrival to cordis laboratory the stent was observed in the bag loose and separated from the device manufacturing position.A functional analysis was attempted to be executed to determine if the deployment mechanism was not compromised in the received unit.This analysis could not be fully evaluated as the stent was not in manufacturing position.Nevertheless, the stent delivery mechanism was activated after the device was prepped per the instructions for use, flushing of the unit was performed and loosening of the torque component.The reported ¿stent delivery system (sds) deployment difficulty premature deployment¿ and ¿stent delivery system (sds) kinked/bent¿ were not confirmed as the stent was received already deployed in the bag received for analysis.The exact cause of the issue experienced by the customer could not be determined.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 and product analysis, it is not possible to determine what factors may have contributed to the issue experienced by the customer.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 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: 18519384
• MDR Text Key: 332940332
• Report Number: 9616099-2024-00016
• 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: 03/15/2024

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 Operator: Health Professional
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 18198294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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