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

Catalog Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

As reported, after delivering an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system to the left internal carotid artery (lica) stenosis, the stent could not be released.When the device was removed, a partial stent deployment was observed.A new 8mm x 40mm precise pro rx ses was used to complete the procedure.Ther were no reported injuries to the patient.This was during a procedure to treat a 70% stenosed lesion with moderate tortuosity.An 8f 90cm multipurpose vista brite tip guiding catheter was used during this procedure.The precise pro rx was stored and prepped per the instructions for use (ifu).The user maintained a fixed inner shaft position during attempted deployment.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was discarded and will not be returned.

Manufacturer Narrative

Complaint conclusion: as reported, after delivering an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system to the left internal carotid artery (lica) stenosis, the stent could not be released.When the device was removed, a partial stent deployment was observed.A new 8mm x 40mm precise pro rx ses was used to complete the procedure.Ther were no reported injuries to the patient.This was during a procedure to treat a 70% stenosed lesion with moderate tortuosity.An 8f 90cm multipurpose vista brite tip guiding catheter was used during this procedure.The precise pro rx was stored and prepped per the instructions for use (ifu).The user maintained a fixed inner shaft position during attempted deployment.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was discarded and will not be returned.The reported ¿stent delivery system (sds) deployment difficulty partial deployment¿ was not confirmed as the device was not returned for analysis.The exact cause of the issue experienced by the customer could not be determined.It is likely procedural factors and device handling 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 the event reported.According to the instructions for use, which is not intended to mitigate risk, ¿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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.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.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.

• Brand Name: PRECISE PRO RX OUS
• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19163231
• MDR Text Key: 341674037
• Report Number: 9616099-2024-00119
• 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
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18243511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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: 4*30MM STERLING (BOSTON SCI); 6*30MM STERLING (BOSTON SCI); 8F 90CM MP VISTA BRITE TIP GUIDING CATHETER; 8MM X 40MM PRECISE PRO RX SES 18243511; FILTERWIRE (BOSTON SCI)
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 60 KG