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

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter contact#: (b)(6).The product is being returned for analysis, however, it has still not been received.Additional information will be submitted within 30 days of receipt.

Event Description

After the removing the precise pro rx carotid system (5f, 6mm x 30mm, 135 cm) from its packaging, it was found that the delivery shaft was seriously kinked (almost broken).So the surgeon replaced it with another product to complete the procedure.There was no patient injury as the device was not clinically used.The product will be returned for analysis.There was no damage to the shipping box or the product packaging.The device was stored per instructions for use (ifu).A picture has been provided.

Manufacturer Narrative

Based on additional clarification from the account, the correct lot number for the device involved is 17276753.Please note that section (lot# and expiration date have been updated.Section (manufacture date) has also been updated.Please update your file accordingly.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: a report was received that the stent of a 6 x 30mm precise pro rx ous carotid system was seriously kinked and almost broken when it was removed from its¿ packaging.The device was not clinically used and the patient¿s procedure completed with no reported patient injury.A picture of the damage was provided that depicted a cordis product in the retaining tray with a kinked body shaft.The site reported that there was no damaged noted to the shipping box or the product packaging and that the device had been stored according to the instructions for use (ifu).One non sterile precise pro rx ous carotid system, 5f, 6mm x 30mm, 135 cm was received coiled inside a plastic bag with an un-deployed stent and with the hemostasis valve closed.One kink was noted 3.5cm from the id band.No cracked conditions or other discrepancies were found.This kink was confirmed during microscopic analysis.Functional testing of the deployment process was performed without difficulty.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The ¿stent delivery system (sds) - cracked-during prep¿ event was not confirmed.However, a kink was observed on the sds, near to the id band.The exact cause of this condition could not be conclusively determined.According to the ifu, 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.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, 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: 5643992
• MDR Text Key: 44893924
• Report Number: 9616099-2016-00228
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2016

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: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: PC0630XCE
• Device Lot Number: 17276753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/26/2016; 06/09/2016
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 52