MAUDE Adverse Event Report: CORDIS CORPORATION PRECISEPRO RX US CAROTID SYSTE; STENT, CAROTID

Model Number PC0730RXC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 7mm x 30mm precise pro rapid exchange (rx) carotid stent system couldn't be delivered to the target site then the doctor found the tip was ripped and fragmented.There was no reported patient injury.The device was opened in sterile field.The device was contaminated but will be returned for 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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 7mm x 30mm precise pro rapid exchange (rx) carotid stent system couldn't be delivered to the target site then the doctor found the tip was ripped and fragmented.There was no reported patient injury.The device was opened in sterile field.The damage was noted during use inside the patient.When removed from the tray, the stent was still constrained within the outer member/sheath.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.A non-cordis 7f sheath introducer was used.A non-cordis 7f guiding catheter was used.The device was contaminated but will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: a precise pro rapid exchange (rx) 7mm x 30mm carotid stent system couldn't be delivered to the target site, then the doctor found that the tip was ripped and fragmented.The device was opened in a sterile field.The damage was noted during use inside the patient.When removed from the tray, the stent was still constrained within the outer member/sheath.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.A non-cordis 7f sheath introducer was used.A non-cordis 7f guiding catheter was used.There was no reported patient injury.One non-sterile precisepro rx us carotid system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked.Per visual analysis, stent was observed deployed from the unit approximately 1.5 mm.Also, the body/catheter of the unit was observed kinked approximately at 0.6 cm from the strain relief.The tip of the catheter was observed placed on the catheter and no anomalies were observed on it.No other anomalies were observed.Per functional analysis, deployment test was performed successfully; neither resistance nor any anomalies were observed during the test.No damages were observed on the stent.A product history record (phr) review of lot 17916479 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - separated - in patient¿ was not confirmed since the tip of the catheter was observed placed on the catheter and no damages/anomalies were observed on it.Also, the stent was observed deployed approximately 1.5 mm from the unit, as received.Additionally, a deployment test was performed successfully; neither resistance nor any anomalies were observed during the test.Nevertheless, the cause of the pre-deployment and the kinked condition observed on the unit, could not be conclusively determined.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics (although unknown) may have led to the reported event as well as the observed kinked condition and pre-deployment condition on the device, as received.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.Verify that the delivery system¿s radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.B.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.C.Ensure that the access sheath or guiding catheter does not move during deployment.D.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand (often referred to as the ¿pin-and-pull¿ method).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: PRECISEPRO RX US CAROTID SYSTE
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10896624
• MDR Text Key: 218269429
• Report Number: 9616099-2020-04081
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036457
• UDI-Public: 20705032036457
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PC0730RXC
• Device Catalogue Number: PC0730RXC
• Device Lot Number: 17916479
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR