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

Model Number PC0840RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Not Applicable (3189)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

During a right internal carotid artery stenting procedure, the precise pro rx self-expanding stent delivery system (ses) could not cross the lesion in the heavily calcified right internal carotid artery (ica).No patient injury was reported.No information was reported regarding how the procedure was completed.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The device was prepped in the tray.When removed from the tray, the stent was not constrained within the outer member/sheath.The tuohy borst valve was closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the stent delivery system (sds).The patient had right and left ica stenosis.The intended lesion was not located at the carotid bifurcation.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.There was difficulty encountered while advancing/tracking the sds towards the lesion.There was unusual force used during the procedure.The lesion was pre-dilated prior to stent implantation.An unknown 4x40 balloon catheter was used to pre-dilate the lesion prior to stent implantation.Nominal pressure was used.The percent of stenosis after pre-dilation is 60%.The contrast was mixed with saline and the ratio of the contrast to fluid was 2:1.There was difficulty advancing the sds over the guidewire or embolic protection device.The difficulty occurred in the vessel.No additional information was reported.The device was not returned for analysis.A product history record (phr) review of lot 17724100 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent delivery system (sds)-ses failure to cross¿ and ¿stent delivery system (sds)-ses deployment difficulty - premature/prior to use¿ could not be confirmed.The device was not retuned for analysis and procedural films were not received.The exact cause could not be determined.Vessel characteristics, as well as procedural and handling factors may have contributed to the reported events.According to the instructions for use (ifu), ¿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.If resistance is met during delivery system introduction, the system should be withdrawn, and another system used.¿ the phr review does not suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the physician attempted to stent a heavily calcified right internal carotid artery (ica) but the precise pro rx self-expanding stent delivery system (ses) could not cross the right common carotid artery.No patient injury was reported.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The device was prepped in the tray.When removed from the tray, the stent was not still constrained within the outer member/sheath.The tuohy borst valve was closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the stent delivery system (sds).The patient had right and left ica stenosis.The intended lesion was not located at the carotid bifurcation.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.There was difficulty encountered while advancing/tracking the sds towards the lesion.There was unusual force used during the procedure.The lesion was pre-dilated prior to stent implantation.An unknown 4x40 balloon catheter was used to pre-dilate the lesion prior to stent implantation.Nominal pressure was used.The percent stenosis after pre-dilation was 60%.The contrast was mixed with saline and the ratio of the contrast to fluid was 2:1.The user thinks that the event was related to both the stent and procedure.There was difficulty advancing the sds over the guidewire or embolic protection device.The difficulty occurred in the vessel.The procedure completion was delayed.Additional details have been requested but were unknown.

• 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 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8033248
• MDR Text Key: 126657402
• Report Number: 9616099-2018-02488
• Device Sequence Number: 1
• Product Code: NIM
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2018

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: 09/30/2019
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17724100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2017
• 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