MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC0520RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17775355 presented no issues during the manufacturing process that can be related to 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, it was found that a precise pro rx self-expanding stent (ses) got deployed little before usage.The device was not used.There was no reported patient injury.The intended procedure was carotid artery stenting (cas).The product was stored properly according to the instructions for use (ifu) and there was nothing unusual noted about the stent delivery system prior to use.The product was prepped properly according to the ifu and it was prepped in the tray.The tuohy borst valve was closed prior to removing the device from the tray.The procedure was completed with a new precise pro rx ses.The device is expected to be returned for analysis.

Manufacturer Narrative

It was found that a precise pro rx self-expanding stent (ses) got deployed a little before usage.The device was not used.There was no reported patient injury.The intended procedure was carotid artery stenting (cas).The product was stored properly according to the instructions for use (ifu) and there was nothing unusual noted about the stent delivery system prior to use.The product was prepped properly according to the ifu and it was prepped in the tray.The tuohy borst valve was closed prior to removing the device from the tray.The procedure was completed with a new precise pro rx ses.The product was returned for analysis.One non-sterile precise pro rx us carotid system 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 partially locked/ closed.The stent of the unit was received already fully deployed.The stent delivery system was damaged at 25.6 cm, at 36.7 cm, and at 139.9 cm from tip.There was a kink at 145.8 cm from tip, on the id band area, at the level of juncture of body to the valve of the delivery system.However, it could not be determined if the compressed and kinked conditions were produced during the reported event or during the transportation of the returned unit.The deployed stent was thoroughly inspected, and no anomalies were observed that could contributed to the reported event.No other anomalies found.Functional analysis could not be completed due to the stent having been deployed previously.Per dimensional analysis the device was within specification.A product history record (phr) review of lot 17775355 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/during prep¿ could not be confirmed as the device could not be evaluated due to the condition of the device being deployed and without the provision of procedural images for review.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event as evidenced by kinks and compressions, and the deployment of the stent, 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 nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8975183
• MDR Text Key: 198348563
• Report Number: 9616099-2019-03191
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036389
• UDI-Public: 20705032036389
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: PC0520RXC
• Device Lot Number: 17775355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1