MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 40MM, 135 CM; STENT, CAROTID

Model Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review of lot 17727951 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f precise pro rx carotid system 7mm x 40mm 135cm self-expanding stent has been released prior to delivery to the sheath and it cannot continue to be used.There was no reported patient injury.The stent became prematurely deployed prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).There were not any anomalies noted when removed from the package.The product was inspected and prepped according to the ifu.There were anomalies noted during prep.The device was not resterilized.There was not excessive torquing required.The device did not kink in the area of the separation.The device did not kink in the area of separation.Resistance was not met while withdrawing the device.The device separated about 1cm from the distal end.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.The lesion was at 40% stenosis after pre-dilation.No unusual force was applied during deployment of the stent.

Manufacturer Narrative

Complaint conclusion: a 5f precise pro rx carotid system 7mm x 40mm 135cm self-expanding stent has been released prior to delivery to the sheath and it cannot continue to be used.There was no reported patient injury.The lesion was at 40% stenosis after pre-dilation.The stent became prematurely deployed prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).There were not any anomalies noted when removed from the package.The product was inspected and prepped according to the ifu.There were anomalies noted during prep.The device was not resterilized.There was not excessive torqueing required.The device did not kink in the area of the separation.The device did not kink in the area of separation.Resistance was not met while withdrawing the device.The device separated about 1cm from the distal end.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.No unusual force was applied during deployment of the stent.The product was returned for analysis.One non-sterile precise pro rx ous carotid system, 5f, 7mm x 40mm, 135 cm stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked / closed.Per visual analysis, the stent of the unit was received 8mm pre-deployed.The hypo tube rod was observed kinked / bent damaged at 2.0 cm and at 12.5 cm from the id band.However, it could not be determined if the bent condition observed could be produced during the reported event or during transportation of the returned unit for analysis.No other anomalies found.Per functional analysis a deployment test was successfully performed despite the damaged condition of the device.The valve of the stent delivery system was unlocked / opened.The stent was completely deployed.Neither difficulty nor anomaly (resistance, friction, or incomplete stent deployment) was experienced during the deployment procedure.Per dimensional analysis the device was found within specification.A product history record (phr) review of lot 17727951 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 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 or handling factors may have contributed to the event as evidenced by kinks noted on the device during analysis.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.¿ 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 at this time.

• Brand Name: PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 40MM, 135 CM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8767261
• MDR Text Key: 150287612
• Report Number: 9616099-2019-03057
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• 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: PC0740XCE
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17727951
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1