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

Catalog Number PC0640XCE

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The correct awareness date is august 10th, 2015 and was incorrectly noted in the previous report.

Manufacturer Narrative

(b)(6).The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the procedure, during the follow-up examination of the patient, the doctor noted that the stent had a fracture in its structure.There was no report of patient injury.The device is still implanted in the patient.The device is not available for analysis.

Manufacturer Narrative

A report was received that the stent of a 6 x 40mm 135cm precise pro rx carotid system fractured sometime after having been implanted.There was no report of patient injury.Attempts to obtain images and/or films of the index or subsequent procedures and to obtain further information about this event have been unsuccessful.The device remains implanted in the patient and is thus not available for return to the manufacturer.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Without the return of the device for analysis or films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.The instructions for use (ifu) directs users to perform an arterial angiogram to verify full deployment of the stent.If incomplete stent expansion exists, post-deployment dilatation can be performed at the discretion of the physician.The clinical implications of stent fractures are not well characterized.Nitinol fatigue leading to stent fractures is a well-known and documented intermediate and long term issues in the distal sfa.Deployment of stents in these types of lesions present multiple forces at work including flexion, torsion, longitudinal expansion and contraction.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported event.Based on the device history record review, there is no indication that the 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: 5333057
• MDR Text Key: 35130134
• Report Number: 9616099-2015-00679
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: PC0640XCE
• Device Lot Number: 15513386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1