MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X30; STENT, CAROTID

Model Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 02/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During transportation of the precise pro self expanding stent delivery system (sds) in patient, the stent is unloaded.There was no patient injury.The target lesion is the internal carotid artery with mild tortuosity, and ninety percent stenosis.The precise sds was prepped per the instruction for use and there were no difficulties flushing the device or any of its components.The device will be returned for analysis.

Manufacturer Narrative

Additional information was received and the device was returned for analysis without the tip.Therefore, catheter tip - separated was added to the malfunction code.

Manufacturer Narrative

During transportation of the precise pro self-expanding stent delivery system (sds) in patient, the stent is unloaded.Additional information was received, and the device was returned for analysis without the tip.The target lesion is the internal carotid artery with mild tortuosity, and ninety percent stenosis.The precise sds was prepped per the instruction for use and there were no difficulties flushing the device or any of its components.There was no patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx 9x30¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed, observing that the distal tip is missing, and it was not returned for analysis.The unit was returned fully deployed, and the stent was not returned for analysis.The hemostasis valve was returned closed tight.No other outstanding details were noticed.Dimensional analysis was performed to verify the usable length.Dimensional analysis result was found within specification.Functional analysis was not performed due to the unit was returned fully deployed.The unit was evaluated by the pet members using a vision system to obtain a magnified image of the separated area.The analyzed unit presented evidence of elongations and bulged/peeled off material on the separated edges which are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the inner shaft material was induced to a tensile force that exceeded the braid wire and inner shaft material yield strength prior to the separation.The event was replicated with a lab sample applying excessive force over the distal tip and it was analyzed using the vision system.It was observed that the lab sample presents the same damages characteristics that the returned unit.A product history record (phr) review of lot 18040181 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 - premature deployment¿ was not confirmed since the device was returned fully deployed and the usable length was found within specification.The reported ¿catheter tip~ separated¿ was confirmed, the unit presented a tip separation condition.The exact cause of the tip separation could not be conclusive determined during the analysis.The analyzed unit presented evidence of elongations and bulged/peeled off material on the separated edges which are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the inner shaft material was induced to a tensile force that exceeded the braid wire and inner shaft material yield strength prior to the separation.Procedural factors such as vessel characteristics (mild tortuosity, and ninety percent stenosis) may have contributed to the reported events.Additionally handling factors such as the user¿s interaction with the device may have contributed to the reported events.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.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.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 9X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13847271
• MDR Text Key: 287610284
• Report Number: 9616099-2022-05473
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

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: 06/30/2023
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18040181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2022
• Initial Date FDA Received: 03/22/2022
• Supplement Dates Manufacturer Received: 03/26/2022; 05/03/2022
• Supplement Dates FDA Received: 04/29/2022; 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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.