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

Model Number PC1040RXC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

As reported, the stent of a precise pro rx carotid stent system could not be deployed during a carotid artery stenting (cas) procedure.The operator flushed the stent sufficiently and deployed it several times.The stent is only "tensioned" and could not be deployed at all; therefore, the operator removed the device.The stent was attempted to be deployed several times.Deployment did not work so the device was removed from the patient and then tried from the outside.There were no issues when the operator used another unknown same sized device.There were no reports of patient injury.The precise pro device was used in accordance with the instructions for use (ifu).After the procedure, the operator forced the device outside and deployed it and the stent was deployed only until it opened.There were no visible signs of device/package damage prior to use.The stent was attempted to be deployed several times.Deployment did not work so the device was removed from the patient and then tried from the outside.The stent could not be deployed at all.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The intended lesion was located at the carotid bifurcation.The target lesion vessel (internal carotid artery [ica]) diameter was 7mm and 2cm in length.An 8f non cordis sheath was used along with a cordis vista brite tip 8f guide catheter.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was 80% stenosis of the ica with mild calcification and no tortuosity.The stent delivery system passed through acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The lesion was pre-dilated prior to stent implantation using a cordis aviator balloon catheter inflated to nominal pressure.The percent stenosis after pre-dilation was 60%.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The tuohy borst (hemostasis) valve was in the open position when received.The stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.The operator applied pressure for deployment, but it was not deployed.The user maintained a fixed inner shaft position during deployment attempt.There was no unusual force applied during deployment attempt of the stent.The device will be returned for evaluation.Addendum: product analysis demonstrates that the distal end of the outer sheath presents a torn condition.

Manufacturer Narrative

The product history review is expected but has not been completed.This device has been analyzed but the final approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: the stent of a precise pro rx carotid stent system could not be deployed during a carotid artery stenting (cas) procedure.The operator flushed the stent sufficiently and deployed it several times.The stent is only "tensioned" and could not be deployed at all; therefore, the operator removed the device.The stent was attempted to be deployed several times.Deployment did not work so the device was removed from the patient and then tried from the outside.There were no issues when the operator used another unknown same sized device.There was 80% stenosis of the ica with mild calcification and no tortuosity.There were no reports of patient injury.The precise pro device was used in accordance with the instructions for use (ifu).After the procedure, the operator forced the device outside and deployed it, and the stent was deployed only until it opened.There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of the precise pro device and has used it several times prior to this procedure.The stent was attempted to be deployed several times.Deployment did not work so the device was removed from the patient and then tried from the outside.The stent could not be deployed at all.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was nothing unusual noted about the stent delivery system prior to use.The intended lesion was located at the carotid bifurcation.The target lesion vessel (internal carotid artery [ica]) diameter was 7mm and 2cm in length.An 8f non-cordis sheath was used along with a cordis vista brite tip 8f guide catheter.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system passed through acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The lesion was pre-dilated prior to stent implantation using a cordis aviator balloon catheter inflated to nominal pressure.The percent stenosis after pre-dilation was 60%.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.The stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.The operator applied pressure for deployment, but it was not deployed.The user maintained a fixed inner shaft position during deployment attempt.There was no unusual force applied during deployment attempt of the stent.The product was returned for analysis.A non-sterile unit of precise pro rx us carotid system was received for analysis coiled inside of a clear plastic bag.Per visual analysis a partial stent deployment was noted.The distal end of the outer sheath presents a torn condition.A kinked condition was observed at 25 cm from the proximal end.The hemostasis valve is tightly closed.No other outstanding details were observed.Per dimensional analysis the stroke length of the stent delivery system was measured and was found within specification.The usable length of the stent delivery system was measured and was found within specification.Per functional analysis the hemostasis valve was unlocked.The stent deployment functionality 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.The unit was evaluated observing that the deploying mechanism is working as expected.However, the stent is stuck and could not be deployed.Per microscopic analysis no damages were noted on the partially deployed stent.A product history record (phr) review of lot 18016037 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn¿ was confirmed through analysis of the returned device.The reported ¿stent delivery system (sds)-ses deployment difficulty -unable¿ was 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, vessel characteristics (a rate of stenosis of 80% and mild calcification) and procedural factors (operator attempted to deploy the device several times) may have contributed to the catheter tip frayed/split/torn event as evidenced by a kink 25cm from the distal tip and a torn distal outer sheath noted during analysis.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 stent deployment difficulty-unable event experienced by the customer could be related to the manufacturing process, as the stent is stuck yet the deployment mechanism is working.A risk assessment has been opened to further investigate this issue.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• 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: 15478115
• MDR Text Key: 305605107
• Report Number: 9616099-2022-06008
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030047
• 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
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 18016037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: UNKNOWN SAME SIZED DEVICE ,TERUMO 8F SHEATH, VISTA