MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX OUS; STENT, CAROTID

Catalog Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

As reported, the 9x40 precise pro rx stent could not be released and opened.The product evaluation showed that the stent was partially deployed approximately 1 cm.The case was completed with the use of a non-cordis stent.There was no reported injury to the patient.The device was prepped while in the tray.The touhy-borst valve was in the open position when received.The touhy-borst valve was opened when removed from the tray.The stent was still constrained within the outer member/sheath when removed from the tray.The stopcock was connected to the y-connector of the touhy-borst valve.There was no difficulty flushing the stopcock or while flushing the sds.The carotid artery had a stenosis.The lesion was at the carotid bifurcation.The lesion was measured to be 7.7mm in diameter.The lesion length was 33mm.The lesion had a 90% stenosis.The lesion was not calcified.The vessel was noted to have mild tortuosity.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 no difficulty encountered while advancing/tracking the sds towards the lesion.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated.After dilatation, the lesion had a 60% stenosis.There was no difficulty or resistance noted while crossing the lesion with the device.The sds did not have to pass through a previously placed stent.The user maintained a fixed inner shaft position during deployment.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the 9x40mm precise pro rx stent could not be released and opened.The case was completed with the use of a non-cordis stent.There was no reported injury to the patient.The device was prepped while in the tray.The touhy-borst valve was in the open position when received and was opened when removed from the tray.The stent was still constrained within the outer member/sheath when removed from the tray.The stopcock was connected to the y-connector of the touhy-borst valve.There was no difficulty flushing the stopcock or while flushing the stent delivery system (sds).The carotid artery had a 90% stenosis that was not calcified.The lesion was at the carotid bifurcation.The lesion was measured to be 7.7mm in diameter, and the length was 33mm.The vessel was noted to have mild tortuosity.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 no difficulty encountered while advancing/tracking the sds towards the lesion.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated.After dilatation, the lesion had a 60% stenosis.There was no difficulty or resistance noted while crossing the lesion with the device.The sds did not have to pass through a previously placed stent.The user maintained a fixed inner shaft position during deployment.A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis.Per visual analysis, a thorough inspection was performed on the unit observing the following conditions: the device was not deployed; however, the stent was partially deployed approximately 1cm; and the hemostasis valve was returned disassembled.No other outstanding details were observed.Per dimensional analysis, the stroke length was measured, and results were found within specification.Functional analysis was performed to determine if the stent could be deployed as expected.The hemostasis valve of the stent delivery system was unlocked.The stent deployment functionality test was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.However, the push rod did not travel toward the distal tip as expected, and it was not possible to deploy the stent.The unit was further evaluated, observing that the deployment mechanism was not working as expected as the inner shaft seems to be stuck inside the inner lumen.The product engineering team (pet) members performed several cross-section cuts to find out the condition of the inner shaft.Several sections were evaluated with a vision system by the pet, observing that the polyamide (black material) was strongly affixed to the inner shaft.A product history record (phr) review of lot 18121321 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿stent delivery system (sds)-deployment difficulty-unable¿ was confirmed through analysis of the returned device due to the inability to deploy the stent during functional analysis.Additionally, the returned unit presented a condition of ¿stent delivery system (sds)-deployment difficulty-partial deployment¿ as the stent was partially deployed 1cm.The cause of the deployment difficulty experienced by the customer was due to the polyamide adhering to the inner lumen of the device.According to the instructions for use (ifu), which is not intended as a mitigation, ¿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.¿ based on the product analysis, the issue appears to be related to the manufacturing process of the unit; therefore, this event was referenced under an existing risk assessment and investigation.

• Brand Name: PRECISE PRO RX OUS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18534052
• MDR Text Key: 333115888
• Report Number: 9616099-2024-00022
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062456
• UDI-Public: (01)20705032062456(17)240531(10)18121321
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18121321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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: NAV 6 WALLSTENT; UMBRELLA; UNKNOWN BALLOON
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 78 KG