MAUDE Adverse Event Report: CORDIS CORPORATION 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 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The initial reporter¿s phone number is: (b)(6).When doing the left carotid artery (lca) stenting with a precise pro rx ous carotid system, 5f, 7mm x 40mm, 135 cm self-expanding stent (ses), the stent failed to release.Another device was used to successfully complete the procedure.There was no report of patient injury.The target lesion was the carotid artery.The patient was diagnosed with left internal carotid artery stenosis.The patient¿s anatomy included 85% tortuosity.There were no damages or anomalies noted on the device prior to use.The device was handled and prepped properly according to the instructions for use (ifu).There were no anomalies noted during the prep of the device.It is unknown if there was any difficulty experienced to deliver the precise stent delivery system to the lesion.The user did hold the stent delivery system flat and straight outside the patient.The user did maintain a fixed inner shaft position during deployment.Upon receipt of the device it was noted that the stent deployed 0.5cm.The doctor didn¿t note the device was deployed after being removed from the patient.The device was returned for analysis.One non-sterile precise pro rx ous carotid system, 5f, 7mm x 40mm, 135 cm sds was returned.Per visual analysis the stent of the unit was received partially deployed by 0.5cm and the hemostasis valve was received opened.No other damages were noted.Per functional analysis a deployment process was performed and the stent was successfully deployed.Per dimensional analysis the stroke length was measured and was found to be within specification.A device history record (dhr) review of lot 17286331 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-partial deployment (carotid)¿ was confirmed through analysis of the returned device, as the device was in a state of partial deployment when analysed.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (85% tortuosity) may have contributed to the event.The reported ¿stent delivery system (sds) deployment difficulty-unable¿ was not confirmed through analysis of the returned device as the stent was able to be deployed successfully during functional analysis and the device was within specifications.The exact cause of the event could not be determined during analysis.According to the ifu ¿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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.Pull back the stent delivery system until the radiopaque inner shaft markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion.Ensure that the stent delivery system outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.Verify that the delivery system¿s radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.Ensure that the access sheath or guiding catheter does not move during deployment.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand (often referred to as the ¿pin-and-pull¿ method).¿ neither the dhr 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.

Event Description

As reported, when doing the left carotid artery (lca) stenting with a precise pro rx ous carotid system, 5f, 7mm x 40mm, 135 cm self-expanding stent (ses), the stent failed to release.Another device was used to successfully complete the procedure.There was no report of patient injury.The device is available for analysis.The target lesion was the carotid artery.The patient was diagnosed with left internal carotid artery stenosis.The patient's anatomy included 85% tortuosity.There were no damages or anomalies noted on the device prior to use.The device was handled and prepped properly according to the instructions for use (ifu).There were no anomalies noted during the prep of the device.It is unknown if there was any difficulty experienced to deliver the precise stent delivery system to the lesion.The user did hold the stent delivery system flat and straight outside the patient.The user did maintain a fixed inner shaft position during deployment.Upon receipt of the device it was noted that the stent deployed.5cm.The doctor didn't note the device was deployed after being removed from the patient.

• 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: 5510906
• MDR Text Key: 40694340
• Report Number: 9616099-2016-00147
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17286331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR