MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM)

Catalog Number PC0740RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is available for analysis; however, it has not yet been received.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

After the physician took the device out of the package and began prepping the device, the stent jumped out of the system and deployed outside of the patient.The physician is very familiar with the product, and it was prepped according to ifu.The device was not reported to have any anomalies or damages prior to stent deployment.The valve was closed during prep of the device.Another precise stent was used to complete the procedure.There was no patient injury.Target lesion information is unknown at this time.

Manufacturer Narrative

The device was returned for analysis.Complaint conclusion: a report was received that during the preparation of a 4 x 40mm precise pro us carotid stent delivery system (sds), the stent deployed outside of the patient.The procedure was successfully completed with another precise sds with no reported patient injury.The site reported that the involved physician is very familiar with the device and that the sds appeared normal and without damage when taken out of the package.They further reported that the sds was prepped according to the instructions for use (ifu) and that the hemostasis valve was closed during this prep.During this preparation the stent is reported to have ¿jumped out of the system¿ and deployed outside the patient.The procedure was successfully completed with another precise sds with no reported patient injury.One non-sterile precise pro rx us carotid syst 7 x 40 was received coiled inside a plastic bag with a deployed stent and with a closed hemostasis valve.No other discrepancies were found.Functional testing was not performed since the unit was received already deployed.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported "sds - deployment difficulty-premature/during prep" event could not be confirmed since the sds was received with a deployed stent.The exact cause of the reported condition could not be conclusively determined.According to the ifu, users are cautioned that the device is shipped with the hemovalve in the open position.They are further instructed to be careful not to prematurely deploy the stent during preparation.The preparation of the device should be done in the tray with closure of the hemovalve prior to the device¿s removal from the tray.After removing the device from the tray, users are instructed to examine the device for any damage.They are to evaluate the distal end of the catheter to ensure that the stent is contained within the other sheath.They are instructed not to use the device if the stent is partially deployed.If the user suspects that the sterility or performance of the device has been compromised, they are instructed to not use the device.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported event.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5308989
• MDR Text Key: 33833908
• Report Number: 9616099-2015-00661
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17325372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1