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 Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: during an unknown procedure, a precise pro stent (rx 8x40) did not fully open during deployment.There was no patient injury reported.Multiple attempts to gather additional information have been made and were unsuccessful.The device was not returned for analysis.A product history record (phr) review of lot 17744665 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent delivery system (sds)-ses deployment difficulty - partial deployment¿ could not be confirmed as the device was not returned for analysis and procedural films were not received.The exact cause of the event could not be determined.Procedural and handling factors may have contributed to the event reported.Per the instructions for use, which is not intended as a mitigation, ¿precise® pro rx nitinol stent system is shipped with the tuohy borst valve in the open position.Care should be taken not to pre-deploy the stent.The device should be prepped in the tray.After prep, 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.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand.Verify that the delivery system¿s radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.Unlock the tuohy borst proximal valve end connecting the inner shaft and outer sheath of the delivery system.Ensure that the sheath introducer or guiding catheter does not move during deployment.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.¿ the phr review does not suggest that the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, a precise pro stent (rx 8x40) did not fully open during deployment.There was no patient injury reported.The device was clinically used and will be returned for analysis.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 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: 8371403
• MDR Text Key: 137280842
• Report Number: 9616099-2019-02750
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17744665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2018
• 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