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

Catalog Number PC0840RXC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(6).The device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the sales rep, the stent of a precise pro rx stent delivery system (sds) would not deploy when attempting retract catheter.When removed from patient and inspection of device, the entire catheter and outer sheath was separated at the rapid exchange port.Another device was used to complete the procedure.There was no patient injury.The intended procedure was a transverse sinus venous stenting.The lesion was not calcified or tortuous, with a stenosis rate of 70%.For the procedure, a 8x40mm precise pro rx sds was opened.There were no damages or anomalies noted to the device or packaging prior to use.There was no difficulty as the device was removed from the packaging.The product was stored, inspected, handled and prepped according to the instructions for use.The tuohy borst valve was open when the device was received and was closed prior to removal from the packaging tray.When removed from the tray, was the stent was still constrained within the outer member/sheath.A buildup of pressure was not felt when attempting to flush the flushing valve.An ipsilateral approach was made and the precise pro stent was inserted into the patient.There was no difficulty encountered while advancing the sds towards the lesion, and the system did not pass through an acute bend.Thrombus was not present proximal to, at, or distal to the lesion site, and there was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.However, the stent of the precise pro rx stent delivery system (sds) would not deploy when attempting retract the outer sheath catheter.Therefore, the device was removed from the patient without difficulty.There was no unusual force used at any time during the procedure.When removed from patient and inspection of device, the entire catheter and outer sheath was separated at the rapid exchange port.Another 8x40mm precise pro stent was used to complete the procedure.There was no patient injury.

Manufacturer Narrative

Analysis of the product was received: one non-sterile precise pro rx us carotid syst was received coiled inside a plastic bag.Unit was not deployed and the hemostasis valve was received closed.Per visual analysis the outer body was found separated at 22.1cm from brite tip and kinked condition was found at 0.3mm from id band.No other damages were found on the received unit.Even the outer shaft was received separated.The outer member was hold and the deployment functional test was performed according to procedure with no anomalies found.The catheter body od and id were measured near to separated condition and results were found within specification.The separated section was inspected under microscope and elongation characteristics were found at the separated edges.Also sem results show that the body external surface presented evidence of elongation and scratches at the surroundings of the separation.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these separation characteristics.Review of lot 17264572 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Based on the analysis of the returned product, this complaint no longer meets the required criteria for medical device reporting since the reported malfunction of outer sheath separation is not reportable.No further reports will be forthcoming.

• 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: 5247761
• MDR Text Key: 32099890
• Report Number: 9616099-2015-00602
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• 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: PC0840RXC
• Device Lot Number: 17264572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1