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

Catalog Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Before use on the patient, it was reported that the surgeon found part of the 7x40mm precise pro rx stent was out of the protective cover during flushing.The device was changed to a new device to complete the procedure.There was no patient injury reported.The device will be returned for analysis.

Manufacturer Narrative

The gender of the patient is unknown.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was provided by the affiliate.Only "a little" of the stent was found pre-maturely deployed.The physician changed to another product to complete and the procedure was finished successfully.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.The device was prepped in the tray.It is unknown if the tuohy borst (hemostasis) valve was in the open or closed position when received.It is unknown if it was closed prior to removing the device from the tray.It is unknown if the stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock and the sds.Excessive force was not applied while flushing the device.The target lesion was the left carotid artery with severe stenosis.The age and gender of the patient is not available.There was no other product issue noted at the account after the procedure or prior to shipping for inspection.Complaint conclusion: during flushing and before use on the patient, it was reported that the surgeon found part of the 7x40mm precise pro rx stent was protruding out of the protective cover.The device was changed to a new device to complete the procedure.There was no patient injury reported.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.The device was prepped in the tray.It is unknown if the tuohy borst (hemostasis) valve was in the open or closed position when received.It is unknown if it was closed prior to removing the device from the tray.It is unknown if the stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock and the sds.Excessive force was not applied while flushing the device.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 (1mm).Valve was received closed.No other discrepancies were found.The usable length was measured and found within specification.Deployment process test was performed according to procedure and no anomalies were found.A review of the manufacturing documentation associated with this lot presented rejects may be potentially related to the complaint; however, controls are in placed at the assembly and packaging processes to detect damages in body and pod.The rejected units were properly segregated and discarded.The failure ¿sds - deployment difficulty-premature/in patient¿ 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.Rough shipping/handling conditions may also have had an impact on the event.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 DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4027657
• MDR Text Key: 19299894
• Report Number: 9616099-2014-00536
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 16028020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 08/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1