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

Catalog Number PC1040RXC

Device Problem Fracture (1260)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the patient experienced a painful bulge in her neck where an 8mm x 40mm x 135cm precise pro rx nitinol carotid stent was placed.The stent was found to be splitting.This occurred 3 weeks after implantation.The device will not be returned for evaluation.

Manufacturer Narrative

The patient experienced a painful bulge in her neck where an 8mm x 40mm x 135cm precise pro rx nitinol carotid stent was placed.The stent was found to be splitting.This occurred 3 weeks after implantation.The device was not returned for analysis.A product history record (phr) review of lot 17706484 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent-~ fractured could not be confirmed and the exact root cause could not be determined.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that handling and procedural factors such as vessel characteristics as well as the user¿s interaction with the device may have contributed to the reported neck swelling/ stent fracture.According to the instructions for use (ifu) ¿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 act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the stent and instigate vessel remodeling around the stent, producing gaps between the stent and the vessel wall.It should be noted that pharmacological factors including patient compliance with medication regimen and discontinuation of anti-platelet therapy (although unknown) as well as patient history: smoking, diabetes, family history, hypertension, hyperlipidemia, prior cad, obesity (although unknown) may have additionally led to the reported event.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX
• 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.; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14021 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 17015204
• MDR Text Key: 316209834
• Report Number: 9616099-2023-06504
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 10705032036559
• UDI-Public: (01)10705032036559(17)190731(10)17706484
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17706484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2017
• 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