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

Catalog Number PC0830RXC

Device Problem Difficult to Remove (1528)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, after deployment of an 8mm x 30mm precise pro carotid self-expanding stent (ses), the precise pro delivery system would not come out of the patient¿s body.There were no reported injuries to the patient.An 8f infiniti guiding catheter was used during this procedure.The physician is experienced in the preparation and use of the device.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, after deployment of an 8mm x 30mm precise pro carotid self-expanding stent (ses), the precise pro delivery system would not come out of the patient¿s body.There were no reported injuries to the patient.An 8f infiniti guiding catheter was used during this procedure.The physician is experienced in the preparation and use of the device.Additional information was requested but was not provided.The device will not be returned for evaluation.The reported ¿stent delivery system (sds) withdrawal difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.Based on the information provided and the limited procedural details given, it is likely procedural and/or handling factors contributed to the event reported.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.According to the instructions for use, which is not intended to mitigate risk, ¿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.

Event Description

As reported, after deployment of an 8mm x 30mm precise pro carotid self-expanding stent (ses), the precise pro delivery system would not come out of the patient¿s body.There were no reported injuries to the patient.An 8f infiniti guiding catheter was used during this procedure.The physician is experienced in the preparation and use of the device.Additional information was requested but was not provided.The device will not be returned for evaluation.

• 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: 18586764
• MDR Text Key: 334834474
• Report Number: 9616099-2024-00033
• 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
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 18237988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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: 8F INFINITI GUIDE.