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

Catalog Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: 8f vista brite tip sheath introducer.(b)(6).The product was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information wil be submitted within 30 days of receipt.

Event Description

During a carotid stenting procedure, it was reported that the 8.0mmx40.0xx precise pro stent prematurely opened before it was placed into the 8f vista brite tip sheath introducer.There was no report of patient injury.The procedure was completed successfully when they changed to another 9.0x40mm precise pro stent to completed the procedure.This occurred after the product was unwrapped and washed.They attempted to back the stent into its release sheath, but without success.The product will be returned for analysis.The device was stored, handled and prepped according to the ifu.There weren't any damages or other anomalies noted to the device or packaging prior to use.About five segments of the stent prematurely opened, and the stent was opened to 2 centimeters in diameter when the performer attempted to back the device into the release sheath.

Manufacturer Narrative

Complaint conclusion: during a carotid stenting procedure, an 8 x 40mm 5f 135cm precise pro rx ous carotid system was noted to be prematurely deployed prior to its¿ introduction into the catheter sheath introducer (csi).The procedure was successfully completed with another precise pro stent delivery system (sds) with no reported patient injury.The event involved a (b)(6) year old male patient undergoing a carotid stenting procedure in an unknown target lesion.The site reported that the device had been stored, handled and prepped according to the instructions for use (ifu) and no damage or anomaly was noted to the device or its¿ packaging prior to use.The site reported that they noted that about five segments of the stent had prematurely deployed and that the stent was opened to a 2cm diameter when they were advancing the device into an 8f vista brite csi.They attempted to ¿back the stent¿ back into its¿ outer sheath but were unsuccessful.The device was exchanged for another precise pro sds and the procedure successfully completed with no reported patient injury.One non-sterile precise pro rx ous carotid system, 5f, 8mm x 40mm, 135 cm was received coiled inside a plastic bag.The unit was received with its stent pre-deployed about 2cm.The hemostasis valve was received partially opened.A kink was observed on the outer shaft, at 4.7 cm from its¿ distal end.No other discrepancies were found.Functional testing of the stent deployment revealed no anomalies or difficulties despite the kinked condition of the distal section.Dimensional analysis of the usable length revealed that it was within specification.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿sds - deployment difficulty-premature/prior to use¿ event was confirmed based on the visual analysis.The exact cause of the reported event as well as of the distal section kinked could not be conclusively determined.However, procedural/handling factors appear to have impacted on the events experienced by the customer.According to the product ifu, users are cautioned that the device is shipped with the hemovalve in the open position.They are further instructed to be careful not to prematurely deploy the stent during preparation.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.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, procedural and/or handling 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.

• 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: 5193838
• MDR Text Key: 30018419
• Report Number: 9616099-2015-00522
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17216919
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60