MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X40; STENT, CAROTID

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During prep of the precise pro self expanding stent, the stent delivery system (sds) was flushed and it was noticed that the head-end stent had been partially released.There was no patient injury.Another precise was used to complete the procedure.The target lesion is the carotid artery which was eighty percent stenosed and moderate tortuosity.Pre-dilation was performed reducing the stenosis to thirty percent.The precise was stored and handled according to the instruction for use (ifu).The tuohy borst (hemostasis) valve was received in the opened position.The precise sds was inspected and prepped according to the ifu in the tray.While the user was flushing the device, it was noted that the head-end stent had been partially released.The device is available for analysis.No other information was provided.

Manufacturer Narrative

During prep of the precise pro self expanding stent, the stent delivery system (sds) was flushed and it was noticed that the head-end stent had been partially released.Another precise was used to complete the procedure.The target lesion is the carotid artery which was eighty percent stenosed and moderate tortuosity.Pre-dilation was performed reducing the stenosis to thirty percent.The precise was stored and handled according to the instruction for use (ifu).The tuohy borst (hemostasis) valve was received in the opened position.The precise sds was inspected and prepped according to the ifu in the tray.While the user was flushing the device, it was noted that the head-end stent had been partially released.There was no patient injury.The device was returned for analysis.One non-sterile precise pro rx 8x40 stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received opened.Per visual analysis, the stent of the unit was deployed approximately 17 mm.The hypo tube rod was observed bent and the body/shaft of the unit was observed kinked approximately 0.1 cm from the strain relief.No other anomalies were observed.Per dimensional analysis, usable length of unit couldn¿t be properly measured due to the kinked condition of the unit, as received.Per functional analysis, deployment test of the stent was performed successfully; neither resistance nor any anomalies were observed during the test.No damages were observed on the stent.A product history record (phr) review of lot 18039048 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)-ses - deployment difficulty - premature/during prep¿ was confirmed since the stent was observed partially deployed 17 mm from the unit.Usable length of the unit couldn¿t be properly measured due to the kinked condition of the unit, as received.However, the cause of premature deployment, the bent hypo tube rod and the kinked body/shaft observed on the unit could not be conclusively determined during the analysis.Handling factors such as the user¿s interaction with the device during use may had led to the reported events.Per 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.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13044342
• MDR Text Key: 290460084
• Report Number: 9616099-2021-05208
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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 Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18039048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Female
• Patient Weight: 84 KG