MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Model Number PC0940XCE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18050609 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion: during the use of a 9*40 precise pro self-expanding stent delivery system (sds), the sds reached the positioning, an attempt was made to release the y-valve, and it cannot be pulled.Therefore, the stent cannot be released.Another cordis¿s 9*30mm sds was used to complete the procedure.There was no patient injury.The target lesion is the carotid artery with greater than seventy percent stenosis.After pre-dilation, there was forty percent stenosis.The precise sds was stored, handled, inspected, and prepped according to the instructions for use (ifu).The tuohy borst (hemostasis) valve was received in the open state and closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was then connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock or the sds.The type of saline that was used during the prep of the precise was heparin saline.The heparinized saline was used along with another company contrast.500 ml of normal saline and 6000 units of heparin was used.The contrast to saline ratio used was 1 to 1.There was no difficulty inserting the sds in the lesion.There also was no resistance with the guide catheter used in the procedure with the sds.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment attempt.The precise sds stent reached the lesion under dsa, but encounters resistance during release, and multiple attempts (including increased force) fail to release the stent.There was inability to retract the stent release.The user did maintain a fixed inner shaft position during deployment attempt.The sds was then withdrawn from the patient with the stent still in the outer sheath and another cordis sds was used to complete the procedure.There were no damages noted to the sds once removed from the patient.At that time, the stent was transported into the body and found to be very tight and could not be pulled and released, so the damage was reported.There is no separation, and no intervention was required.No other information was provided.The product was returned for analysis.A non-sterile unit of precise pro rx 9x40 sds was received for analysis coiled inside of a clear plastic bag.Per visual analysis the unit presents a several kinked conditions located approximately at 3.5, 25, 65.5, 75.5, 78.5, 83, and 139 cm from the distal end.Also, the hypotube presents a kinked condition located approximately at 9 cm from the distal tip.The hemostasis valve was received tightly closed.The stent was fully deployed and was not returned for analysis.The distal tip is missing.No other damages or anomalies were observed.Dimensional analysis was not performed due to the severe kinked conditions of the returned unit.Functional analysis was not performed due to the severe kinks presents on the returned device.However, the unit was attempted to be deployed manually actuating the mechanism manually, but the inner lumen is stuck impeding the stent deployment.Per microscopic analysis the distal tip is separated from the inner lumen.The separation edge presents evidence of elongations.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the device was induced to a tensile force that exceeded the material yield strength prior to the distal tip separation.A product history record (phr) review of lot 18050609 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 - unable¿ and ¿catheter tip ~ separated¿ were confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, shipping or handling factors may have contributed to the catheter tip separation as this issue was not described in the event description.Indeed, it was noted there were no damages noted on the device.According to the safety information in the instructions for use, ¿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).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 product analysis suggests that the deployment difficulty event experienced by the customer could be related to the manufacturing process.A risk assessment has been opened to further investigate this issue.

Event Description

As reported, during the use of a 9*40 precise pro self-expanding stent delivery system (sds), the sds reached the positioning, an attempt was made to release the y-valve, and it cannot be pulled.Therefore, the stent cannot be released.Another cordis¿s 9*30mm sds was used to complete the procedure.There was no patient injury.The target lesion is the carotid artery with greater than seventy percent stenosis.After pre-dilation, there was forty percent stenosis.The precise sds was stored, handled, inspected, and prepped according to the instructions for use (ifu).The tuohy borst (hemostasis) valve was received in the open state and closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was then connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock or the sds.The type of saline that was used during the prep of the precise was heparin saline.The heparinized saline was used along with another company contrast.500 ml of normal saline and 6000 units of heparin was used.The contrast to saline ratio used was 1 to 1.There was no difficulty inserting the sds in the lesion.There also was no resistance with the guide catheter used in the procedure with the sds.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment attempt.The precise sds stent reached the lesion under dsa, but encounters resistance during release, and multiple attempts (including increased force) fail to release the stent.There was inability to retract the stent release.The user did maintain a fixed inner shaft position during deployment attempt.The sds was then withdrawn from the patient with the stent still in the outer sheath and another cordis sds was used to complete the procedure.There were no damages noted to the sds once removed from the patient.At that time, the stent was transported into the body and found to be very tight and could not be pulled and released, so the damage was reported.There is no separation and no intervention was required.No other information was provided.The device will be returned for evaluation.Addendum: during visual inspection of the device the distal tip was missing.The distal section was inspected with a vision system observing that the distal tip is separated from the inner lumen.

• Brand Name: PRECISE PRO RX 9X40
• 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: 15674464
• MDR Text Key: 303556365
• Report Number: 9616099-2022-06007
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062456
• UDI-Public: (01)20705032062456(17)230831(10)18050609
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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: 10/26/2022

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: 08/31/2023
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18050609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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: ANOTHER CORDIS¿S 9*30MM SDS
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG