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

Catalog Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

As reported, after reaching the target lesion with an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system, the stent could not be released.Upon removal of the 8mm x 40mm precise pro ses from the patient, the stent appeared expanded.As a result, a non-cordis carotid artery stent was used as a replacement without issue.There was no reported injury to the patient.An attempt to fully deploy the 8mm x 40mm precise pro ses outside of the patient was made; however, the stent could only be pushed out about 1cm with excess force.The device was stored, prepped, and handled per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch 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.The target lesion had a vessel diameter of 8mm.There was moderate calcification at the target lesion but no vessel tortuosity.There was no resistance experienced during insertion of the device or during advancement towards the lesion.The delivery system did not have to pass through any previously placed stents or acute bends.The device was able to be removed easily from the patient and remained in one piece during its removal.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18084181 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: after reaching the target lesion with an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system, the stent could not be released.Upon removal of the 8mm x 40mm precise pro ses from the patient, the stent appeared expanded.As a result, a non-cordis carotid artery stent was used as a replacement without issue.The target lesion had a vessel diameter of 8mm.There was moderate calcification at the target lesion but no vessel tortuosity.There was no reported injury to the patient.An attempt to fully deploy the 8mm x 40mm precise pro ses outside of the patient was made; however, the stent could only be pushed out about 1cm with excess force.The device was stored, prepped, and handled per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch 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 experienced during insertion of the device or during advancement towards the lesion.The delivery system did not have to pass through any previously placed stents or acute bends.The device was able to be removed easily from the patient and remained in one piece during its removal.The product was returned for analysis.A non-sterile unit of precise pro rx 8x40mm was received coiled inside of a clear plastic bag.Per visual analysis the stent is partially deployed.Also, an accordioned condition of the outer sheath was observed located approximately at 135.5 cm from the distal tip.The hemostasis valve was returned dissembled from the hub.No other anomalies or damages were observed.Per dimensional analysis the stroke length was found within specification.Per functional analysis the stent deployment functional test was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.But the push rod did not travel toward the distal tip as expected and the stent was not able to be deployed.Several cross sections were cut to find what is impeding the travel of the support member.Per microscopic analysis polyamide was strongly affixed to the support member.A product history record (phr) review of lot 18084181 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¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, polyamide was adhering the outer sheath to the inner shaft noted during analysis.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.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a risk assessment and corrective/preventive action will be taken.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d8, d9, g3, g4, g6, h1, h2, h3, and h10 this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after reaching the target lesion with an 8mm x 40mm precise pro rx self-expanding stent (ses) delivery system, the stent could not be released.Upon removal of the 8mm x 40mm precise pro ses from the patient, the stent appeared expanded.As a result, a non-cordis carotid artery stent was used as a replacement without issue.There was no reported injury to the patient.An attempt to fully deploy the 8mm x 40mm precise pro ses outside of the patient was made; however, the stent could only be pushed out about 1cm with excess force.The device was stored, prepped, and handled per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch 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.The target lesion had a vessel diameter of 8mm.There was moderate calcification at the target lesion but no vessel tortuosity.There was no resistance experienced during insertion of the device or during advancement towards the lesion.The delivery system did not have to pass through any previously placed stents or acute bends.The device was able to be removed easily from the patient and remained in one piece during its removal.The device has now been returned.

• 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 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15447204
• MDR Text Key: 301980954
• Report Number: 9616099-2022-05992
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)240131(10)18084181
• 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,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18084181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: CAROTID ARTERY STENT (ABBOT).
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 52 KG