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

Catalog Number PC0940RXC

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the tuohy borst valve was in open position when received or if it was closed prior to removal from packaging.It is unknown if the stent was still constrained when removed from the packaging.An approach was made from the femoral artery.There was no problem when flushing the precise pro rx sds during preparation, but it is unknown if a build-up of pressure as felt during flushing.The precise stent was delivered with using a non-cordis filter wire.It is unknown if the sds passed through any acute bends or stents, if the delivery was ipsilateral, or if there was any difficulty advancing to or across the lesion.It was delivered to the position of placing and the user attempted to withdraw the outer sheath to deploy the stent.However, the outer sheath could not be moved and the stent could not be deployed.It is unknown if unusual force was used at any time during the procedure or if the user maintained a fixed inner shaft during deployment.It is unknown if there was thrombus around the deployment area.The device was removed from the patient (it is unknown if there was difficulty during removal) and it was found that outer sheath was separated at joint part near the guidewire port.Therefore, the precise stent was changed to new unknown stent (different size).The procedure was finished successfully.There was no reported patient injury.The product was clinically used.And it will be returned for analysis.A frayed condition was observed by failure analysis on tip of catheter.Concomitant devices: filter wire (filterwire ez, boston scientific) and unknown stent to finish the procedure.(b)(4).(b)(6).Complaint conclusion: a 9 x 40mm precise pro rx us carotid system stent could not be deployed.When removed, the reported that the outer sheath was separated at the joint near the guidewire port.The procedure was successfully completed with another device with no reported patient injury.The event involved a male who was undergoing an endovascular intervention of a target lesion in an unspecified location that was described as mildly calcified and non-tortuous.The patient¿s vasculature was accessed via the femoral artery and the target lesion crossed with a non-cordis filter wire.The site reported that the stent delivery system (sds) had been stored, handled, inspected and prepped according to the instructions for use (ifu) and no damages were noted to the packaging or device prior to use.No difficulty was experienced when removing the sds from the packaging or while flushing it during preparation.The user then attempted to withdraw the outer sheath to deploy the stent but was unable to do so and the stent could not be deployed.The sds was removed from the patient and the site reported that the outer sheath was separated at the joint near the guidewire port.The procedure was successfully completed with another device with no reported patient injury.One non sterile unit precise pro rx us carotid syst was received coiled inside a plastic bag with the outer separated from the pod, a non-deployed stent and a frayed brite tip.Dimensional analysis of the stroke length of the pin-pull component revealed that it met specification.Functional testing of the deployment process could not be performed because of the separated outer member.Inspection of the device under the vision system confirmed that the brite tip was frayed and the outer member was separated.Sem analysis of the external body surface and of the frayed brite tip revealed evidence of elongation at the areas surrounding the separation and the fraying.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿sds - deployment difficulty-unable¿ event could not be confirmed because of the observed separation.The reported ¿luer hub - separated-during use¿ was confirmed based on the visual analysis.Further analysis of the device revealed evidence of elongation on the brite tip and outer member consistent with pieces being pulled or stretched.According to the ifu, this device is indicated for use in patients with stenotic lesions of the carotid artery(ies).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.The ifu instructs users to unlock the tuohy borst proximal valve end connecting the inner shaft and outer sheath of the sds.They are to ensure that the sheath introducer or guiding catheter does not move during deployment.The ifu further instructs users to initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, based on the results of the product analysis (evidence of elongation consistent with stretching), procedural factors may have contributed to it.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.

Event Description

As reported, after removing the precise pro rx stent delivery system (sds) from the patient since the stent could not be deployed, it was found that the outer sheath was separated at the joint with the guidewire port.Therefore, another stent was used to complete the procedure.There was no reported patient injury.The patient was a male but his age was unknown.The intended procedure is unknown.The target lesion was the unknown.The lesion was mildly calcified and not tortuous.The rate of stenosis was unknown.For the procedure, a 9x40mm precise pro rx sds was opened.There were no damages or anomalies noted to the device prior to removal from the packaging, or to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging.The product was store, handled, inspected and prepped according to the instructions for use.

• 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: 5352507
• MDR Text Key: 35315727
• Report Number: 9616099-2016-00010
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• 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: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 17260989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1