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

Model Number PC0740RXC

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

As reported, during placement of precise stent over a non-cordis filter and filter wire, there was some resistance after deployment and during removal.The resistance subsided and the precise deployment system was removed.It was then noticed under fluoro that the tip had broken off.This was noticed as the second precise pro stent was being advanced to the lesion.A second stent was needed due to length of the lesion.There was no other malfunction to that first stent.After the second stent was deployed, they were able to remove the filter wire and tip by capturing into the sheath with no harm to patient.Case was an overall success with 2 precise stents placed in the common and internal carotid arteries.There was no reported injury to the patient.The device was prepped while in the tray.The tuohy borst valve was in the normal position/open when received.The tuohy borst valve was closed prior to removing from the tray.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the stopcock or while flushing the sds.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was stored and handled per the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The intended lesion was in the internal carotid.The lesion was not at the bifurcation.The diameter of the lesion was measured to be around 6mm.The lesion was noted to be calcified and the vessel had tortuosity.Resistance was met while advancing the device.There was some difficulty experienced while advancing/tracking towards the lesion.Unusual force was used when the resistance was met.The device will be returned for evaluation.Inner shaft separation was found during the product evaluation.

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.

Manufacturer Narrative

During placement of precise stent over a non-cordis filter and filter wire, there was some resistance after deployment and during removal.The resistance subsided and the precise deployment system was removed.It was then noticed under fluoro that the tip had broken off.This was noticed as the second precise pro stent was being advanced to the lesion.A second stent was needed due to length of the lesion.There was no other malfunction to that first stent.After the second stent was deployed, they were able to remove the filter wire and tip by capturing into the sheath with no harm to patient.Case was an overall success with 2 precise stents placed in the common and internal carotid arteries.The intended lesion was in the internal carotid.The lesion was not at the bifurcation.The diameter of the lesion was measured to be around 6mm.The lesion was noted to be calcified and the vessel had tortuosity.There was no reported injury to the patient.The device was prepped while in the tray.The tuohy borst valve was in the normal position/open when received.The tuohy borst valve was closed prior to removing from the tray.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the stopcock or while flushing the sds.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was stored and handled per the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.Resistance was met while advancing the device.There was some difficulty experienced while advancing/tracking towards the lesion.Unusual force was used when the resistance was met.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 several kinks were noted.One kink is located approximately 25 cm from the proximal end and others 14 and 19 cm from the distal end.Also, a separation in the inner shaft was observed on the distal tip.The separated piece was not returned for analysis.The device is fully deployed, and the stent was not returned for analysis.The hemostasis valve was returned tightly closed.No other damages were noted.Per microscopic analysis the separated area of the inner shaft does not present evidence of elongations.Also, no diameter reduction due to elongations was observed.In both segments were found tears, and therefore it seems the material adjacent to the damage was ruptured by a sharp object from the outside of the device.A product history record (phr) review of lot 18027353 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip fractured - in patient¿ was not confirmed through analysis of the returned device.The reported ¿inner shaft separated - in patient¿ 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, procedural factors may have contributed to the burst as evidenced by tears, likely caused by a sharp object, noted during analysis.Also, several kinks were noted.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.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

Event Description

As reported, during placement of precise stent over a non-cordis filter and filter wire, there was some resistance after deployment and during removal.The resistance subsided and the precise deployment system was removed.It was then noticed under fluoro that the tip had broken off.This was noticed as the second precise pro stent was being advanced to the lesion.A second stent was needed due to length of the lesion.There was no other malfunction to that first stent.After the second stent was deployed, they were able to remove the filter wire and tip by capturing into the sheath with no harm to patient.Case was an overall success with 2 precise stents placed in the common and internal carotid arteries.There was no reported injury to the patient.The device was prepped while in the tray.The tuohy borst valve was in the normal position/open when received.The tuohy borst valve was closed prior to removing from the tray.The stent was still constrained within the outer member/sheath when removed from the tray.There was no difficulty encountered while flushing the stopcock or while flushing the sds.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was stored and handled per the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The intended lesion was in the internal carotid.The lesion was not at the bifurcation.The diameter of the lesion was measured to be around 6mm.The lesion was noted to be calcified and the vessel had tortuosity.Resistance was met while advancing the device.There was some difficulty experienced while advancing/tracking towards the lesion.Unusual force was used when the resistance was met.The device will be returned for evaluation.Inner shaft separation was found during the product evaluation.

• 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: 15631781
• MDR Text Key: 301993770
• Report Number: 9616099-2022-06062
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: PC0740RXC
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 18027353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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: 2 PRECISE STENTS; SPIDER FILTER WIRE; UNK SHEATH
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 100 KG