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

Catalog Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the stent of an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system was unbale to be deployed inside of the patient.It was reported that during the attempted deployment, the stent was only partially deployed.Despite the partial deployment, the device was able to be removed easily from the patient, and a new 8mm x 40mm 135cm precise pro rx ses delivery system was used as a replacement without issue.There was no reported injury to the patient.This was during a procedure to treat internal carotid artery stenosis.The lesion did not have any calcification or vessel tortuosity present.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The stent was still constrained within the outer sheath when removed from its tray.There was no difficulty flushing the stopcock or the delivery system itself.There was no resistance or friction experienced during insertion of the device, and the device was able to track towards the lesion and cross the lesion with ease.The delivery system did not pass through any acute bends or previously placed stents.The device remained in one piece during its removal from the patient.The product was not returned for analysis.A product history record (phr) review of lot 18118795 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 - partial deployment¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural and/or handling factors may have contributed to the reported event.According to the instructions for use, which are not intended as a mitigation of 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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

Event Description

As reported, the stent of an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system was unable to be deployed inside of the patient.It was reported that during the attempted deployment, the stent was only partially deployed.Despite the partial deployment, the device was able to be removed easily from the patient, and a new 8mm x 40mm 135cm precise pro rx ses delivery system was used as a replacement without issue.There was no reported injury to the patient.This was during a procedure to treat internal carotid artery stenosis.The lesion did not have any calcification or vessel tortuosity present.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The stent was still constrained within the outer sheath when removed from its tray.There was no difficulty flushing the stopcock or the delivery system itself.There was no resistance or friction experienced during insertion of the device, and the device was able to track towards the lesion and cross the lesion with ease.The delivery system did not pass through any acute bends or previously placed stents.The device remained in one piece during its removal from the patient.The device was not returned as expected.

• 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; santiago troncoso 808; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15666491
• MDR Text Key: 303557253
• Report Number: 9616099-2022-06067
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)240531(10)18118795
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18118795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Date Device Manufactured: 06/14/2022
• 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: 8MM X 40MM 135CM PRECISE PRO RX SES
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 74 KG