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

Model Number PC0740XCE

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

During the irrigation, the sheath returned back and caused the release of a precise stent.There was no report of patient injury.

Manufacturer Narrative

The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Additional information received indicated that the product was stored, handled and prepped according to the ifu.Prior to use, it was noted that there was a defect.The premature deployment occurred during the prepping of the device.This was a stenting procedure to the carotid artery.The procedure was completed by a using a new precise stent.There was no patient injury as the device was not clinically used.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Partial pre-mature stent deployment occurred during preparation of the stent delivery system.The product was stored, handled and prepped according to the ifu.The procedure was completed by a using a new precise stent.There was no patient injury as the device was not clinically used.There was no report of patient injury.One non-sterile precise pro rx ous carotid system, 5f, 7mm x 40mm, 135 cm was received coiled inside a plastic bag.Unit was received partially deployed (6mm).Hemostasis valve was received closed.No other discrepancies were found.The usable length was measured and found within specification.Functional test (deployment process) was performed according to procedure and no anomalies were found.Review of lot 16046882 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failure ¿sds - deployment difficulty-premature/during prep¿ reported by the customer was confirmed.The cause of this failure could not be conclusively determined; however it does not appear to be manufacturing related since during dimensional and functional analyses no anomalies were found.Controls are in place at the final assembly and packaging process to detect this kind of issue.Neither the dhr review nor the analysis suggests that the failure is manufacturing process.Therefore no actions were taken.The hemovalve of the precise pro rx is shipped in the open position.If the prepping instructions are not properly followed and the valve is not closed prior to removal from the tray it is possible to pre-maturely deploy the stent or to start stent deployment while still in the tray or during removal from the tray.It is possible that the operator's interaction with the sds may have contributed to the reported event if these steps were not followed correctly.However, based on the information provided no conclusion can be drawn.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• 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: 4213494
• MDR Text Key: 5150260
• Report Number: 9616099-2014-00704
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: PC0740XCE
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 16046882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Date Device Manufactured: 02/03/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1