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

Catalog Number PC0930RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 05/13/2023

Event Type  malfunction  

Event Description

As reported, a precise pro rx carotid self-expanding stent could not be used because it could not cross the blood vessel and was bent.There was no reported patient injury.The device was being used in a carotid artery stenting (cas) case.Multiple attempts to gather additional information have been made and have been unsuccessful.The device was returned for analysis.According to the product evaluation, the stent was partially deployed when received.Per the sales representative, it is difficult to confirm when the stent deployment occured; if the stent deployed deployed during the procedure or if this occurred during shipping.

Manufacturer Narrative

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

Manufacturer Narrative

A precise pro rx carotid self-expanding stent could not be used because it could not cross the blood vessel and was bent.The device was being used in a carotid artery stenting (cas) case.Multiple attempts to gather additional information have been made and have been unsuccessful.The device was returned for analysis.According to the product evaluation, the stent was partially deployed when received.Per the sales representative, it is difficult to confirm when the stent deployment occurred; if the stent deployed during the procedure or if this occurred during shipping.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid system¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.The unit was thoroughly inspected observing the following conditions: the stent is partially deployed; the push rod is set in a partially deployed condition; the hemostasis valve was received locked; a kink was observed located approximately on 2.3 cm from the distal tip.No other outstanding details were observed.Dimensional analysis was performed to verify the correct od of the stent crossing profile.Dimensional analysis results were found within specification.Functional test related to the failure to cross malfunction was not performed due to the nature of the complaint; the reported malfunction is not possible to reproduce in a laboratory environment.The functionally of the device was verified to determine if the stent can be deployed as expected.The hemostasis valve was unlocked.The stent deployment functionally test was initiate by retracting the outer sheath while holding the inner shaft in a fixed position.The push rod travel toward the distal tip as expected and the stent was deployed.The stent expands normally presenting no damages or anomalies.A product history record (phr) review of lot 18041675 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-failure to cross¿ could not be confirmed due to the nature of the complaint and due to the od of the stent crossing profile was found within specification.The reported ¿stent delivery system (sds)-kinked/bent¿ was confirmed, a kink was observed on the returned device.Also, a partial stent deployed condition was observed.The exact cause of the kink and the partial deployed condition observed on the device could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.Open the outer box to reveal the pouch containing the stent and delivery system.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings section.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply positive pressure until saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.Close the stopcock attached to the tuohy borst y connection.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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

According to the product evaluation, the stent was partially deployed when received.Per the sales representative, it is difficult to confirm when the stent deployment occurred; if the stent deployed during the procedure or if this occurred during shipping.

• Brand Name: PRECISE PRO RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17772473
• MDR Text Key: 323698573
• Report Number: 9616099-2023-06597
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036518
• UDI-Public: (01)20705032036518(17)230630(10)18041675
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: PC0930RXC
• Device Lot Number: 18041675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Date Device Manufactured: 07/30/2021
• 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: N/A.