MAUDE Adverse Event Report: CORDIS CORPORATOIN PRECISE PRO RX US CAROTID SYST; SELF EXPANDABLE STENT

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When the pouch of an 8x30mm precise pro rx stent was opened for a carotid artery stenting (cas) case, the stent was already deployed by approximately 2 mm.It was replaced with a non cordis stent and the procedure was completed.There was no patient injury and the device will be returned for analysis.The physician commented that this issue might have caused by being hooked with something.

Manufacturer Narrative

When the pouch of an 8x30mm precise pro rx stent was opened for a carotid artery stenting (cas) case, the stent was already deployed by approximately 2 mm.It was replaced with a non cordis stent and the procedure was completed.There was no patient injury.The physician commented that this issue might have caused by being hooked with something.The product was returned for analysis.One non-sterile precise pro rx us carotid stent delivery system was received for analysis inside a plastic bag.Per visual analysis no original packaging was returned.The valve of the unit was received locked.The stent of the unit was received deployed approximately 0.7 cm.No other anomalies were observed.Per functional analysis a deployment test was performed successfully on the unit; 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 17847203 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) - deployment difficulty - premature/during prep¿ 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 may have contributed to the event as a deployment test was performed successfully, and no anomalies were experienced during the test.Also, no anomalies were observed on the stent.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 US CAROTID SYST
• Type of Device: SELF EXPANDABLE STENT
• Manufacturer (Section D): CORDIS CORPORATOIN; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9163035
• MDR Text Key: 169356050
• Report Number: 9616099-2019-03258
• Device Sequence Number: 1
• Product Code: NIM
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 17847203
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN STENT.