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

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

As reported, after releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.A unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The device will be returned for evaluation.Image review: the image shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to sheathe the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18065771 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.

Event Description

As reported, after releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.A unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The device will be returned for evaluation.Image review: the image shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to resheath the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.After releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.An unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The product was not returned for analysis.A picture was provided for review which showed the stent partially deployed.A product history record (phr) review of lot 18065771 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 picture provided for review.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) or procedural/handling factors may have contributed to the event.According to the instructions for use, which are not intended as a mitigation of risk, ¿preparation of stent delivery system caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.A.Open the outer box to reveal the pouch containing the stent and delivery system.B.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings section.C.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.D.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.E.Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply positive pressure until saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.F.Close the stopcock attached to the tuohy borst y connection.G.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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.The instructions for use advises the user to "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".¿initiate stent deployment by rotating the tuning dial with thumb and index finger in a clockwise direction (direction of arrow) while holding the handle in a fixed position.Note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.¿ neither the phr review, the provided device image nor the very limited information suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, after releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.An unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The device will be returned for evaluation.The image review shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to re-sheath the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d9, g3, h1, h2, h3 and h6 this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, after releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.An unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The device will be returned for evaluation.The image review shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to re-sheath the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.

Manufacturer Narrative

After releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.An unknown guide catheter was used to push forward and remove the stent.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The image review shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to re-sheath the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.There was no reported injury to the patient.The product was returned for analysis.A picture was provided for review which showed the stent partially deployed.A product history record (phr) review of lot 18065771 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 picture provided for review.A non-sterile unit of ¿precise pro rx 8x40¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the evaluation.The unit was thoroughly inspected observing that the unit present a stent partial deployment condition.Despite the partial deployment condition, the stop that push the stent remains in their original position.A kink on the hypotube was observed approximately at 11 cm from the proximal end.The hemostasis valve was returned tight closed.No other outstanding details were observed.The stroke length was not measured due to the kinked condition on the hypotube.Dimension analysis result for usable length the were found within specification.Functional analysis was performed to determine if the stent can be deployed as expected.The hemostasis valve was unlocked from the stent delivery system.The stent deployment functionally test was initiate by retracting the outer sheath while holding the inner shaft in a fixed position.However, the push rod did not travel toward towards the distal tip as expected and as a result, it was not possible to deploy the stent.The unit was evaluated observing that the deploying mechanism is not working as expected, it seems to be stuck inside the inner lumen.Several cross-section cuts were performed to identify what might be impeding the travel of the support member.The stuck section was evaluated with a vision system, and it was observed that the polyamide was strongly affixed to the inner shaft.A product history record (phr) review of lot 18065771 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, the returned unit does present a partial stent deployment.The functional test failed, and the stent was not deployed as expected because the polyamide is adhered to the inner shaft.According to the instructions for use, which is 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 corrective/preventive action will be taken at this time.

Event Description

As reported, after releasing the precise pro rx 8x40 at the lesion location, it was found that the stent was half released.An unknown guide catheter was used to push forward and remove the stent.There was no reported injury to the patient.The operator removed the precise from the packaging and rinsed it normally.It was pushed with the guidewire and released.The device will be returned for evaluation.The image review shows a precise pro stent delivery system with a partially deployed stent in situ.The stent appears to have been pushed forward from its normal seating, possibly when there was an attempt to re-sheath the stent and again when a catheter was used to enable removal of the entire device from the patient.The device is grossly intact with no missing components.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: PRECISE PRO RX OUS
• 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: 15215721
• MDR Text Key: 301568801
• Report Number: 9616099-2022-05898
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)231031(10)18065771
• 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,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18065771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 08/12/2022; 02/27/2023; 03/15/2023; 04/21/2023
• Supplement Dates FDA Received: 08/24/2022; 03/14/2023; 04/12/2023; 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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: UNK GUIDE WIRE; UNK GUIDE WIRE; UNK GUIDE WIRE