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

Model Number	PC0840RXC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: a precise pro 8mm x 40mm carotid self-expanding stent (ses) delivery system was attempted to be used because there was a lesion on the carotid side; however, the stent did not pass through the blood vessel.There was no reported patient injury.The device was returned for analysis and a separation condition was observed located at 2 cm from the distal tip.The device was returned for analysis.A non-sterile unit of product ¿precise pro rx us carotid syst¿ was received coiled inside of a clear plastic bag.The device was unpacked and laid on a tray to perform the evaluation.The stent of the unit was received already deployed and expanded.A separation condition was observed located at 2 cm from the distal tip.The separated segment was included at the packaging.A kinked bent condition located at 4 cm from the distal tip was observed.Apparently, this damage was caused by the packaging, due to the unit was bent to fit inside the plastic bag.The hemostasis valve was received close tighten.The tip of the separated segment was pulled out and it remained at place.No other damages or anomalies were observed at the inspected device.Microscopic results showed that the separated area of wire lumen of the precise pro rx us carotid syst unit presented a tear, elongations, and flared condition.Also, the braid wire from the wire lumen presented evidence of plastic deformation and diameter reduction.The elongations and flared condition found on the wire lumen material, and the plastic deformation and diameter reduction observed on the braid wires are commonly associated with separations caused by material tensile overload.The tear observed on the wire lumen material is commonly caused during the interaction of the unit material with a sharp object or mechanical damage.Therefore, it is assumed that the wire lumen material was induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation and that the wire lumen material was torn near to the separation area either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from the outside of the device.No other anomalies were observed during the microscopic analysis.Per functional analysis, functional test could not be performed due to the nature of the complaint and due to the separation condition.Dimensional analysis was performed to verify the correct outer diameter (od).Dimensional analysis results were found within specification.A product history record (phr) review of lot 17980245 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.Tracking difficulty¿ could not be confirmed due to the nature of the complaint.The dimensional analysis results of the unit were found within specification.However, a separated condition was observed on the returned unit.The reported ¿catheter tip.Separated¿ was confirmed.A separated condition was observed on the returned device, as received.The exact cause of the observed separation could not be conclusively determined.However, procedural and or handling factors such as the user¿s interaction with the device may have led to the reported tracking difficulty as patient anatomy and user technique can be contributing factors.Additionally, handling factors such as forceful interaction with the device during use and or the way the device was packaged and shipped back for analysis (unit was bent to fit inside the plastic bag) may have led to the reported separated condition of the unit, as received.Furthermore, microscopic results showed that the separated area of wire lumen of the precise pro rx us carotid syst unit presented a tear, elongations, and a flared condition.Also, the braid wire from the wire lumen presented evidence of plastic deformation and diameter reduction.The elongations and flared condition found on the wire lumen material, and the plastic deformation and diameter reduction observed on the braid wires are commonly associated with separations caused by material tensile overload.The tear observed on the wire lumen material is commonly caused during the interaction of the unit material with a sharp object or mechanical damage.Therefore, it is assumed that the wire lumen material was induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation and that the wire lumen material was torn near to the separation area either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from outside of the device.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.¿ per the investigation conducted, the unit was received separated, and the initial event reported tracking difficulty.Although the product analysis revealed tensile forces, the tip of the separated segment was pulled out and it remained at place, per product analysis.Therefore, it is reasonable to consider that a delicate device subjected to tensile forces and then placed in a plastic bag for packaging instead of the units original protective housing provided poor conditions for the unit during transportation back to the facility for analysis.This additional strain on the device during transportation may have contributed to the noted separated condition of the device, as received.This is also made evident by the kink noted on the device as received.Neither the product analysis nor the phr review suggests that the event could be related to the manufacturing process; therefore, no corrective action will be taken at this time.
Event or Problem Description
An 8mm x 40mm precise pro carotid self-expanding stent (ses) delivery system was tried to use because there was a lesion on the carotid side; however, the stent did not pass through the blood vessel.There was no reported patient injury.The device was returned for analysis and a separation condition was observed located at 2 cm from the distal tip.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12148722
• Report Number: 9616099-2021-04698
• Device Sequence Number: 19775098
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17980245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1