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

Catalog Number PC0940RXC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a precise pro rx us carotid system was delivered to the lesion and retracted totally, but it did not deploy.After the precise was removed from the patient, a rupture was confirmed at the wireport area (rapid exchange port).The separation of the outer body was confirmed at the guide wire port into two pieces.Therefore, the stent was changed to another stent and the procedure was completed successfully.There was no report of patient injury.The patient was a female.The target lesion was unknown.The lesion was not calcified and mildly tortuous.The rate of stenosis was unknown.The length of the lesion is unknown.There were no damages or anomalies noted on the device or packaging prior to use.The device was handled and prepped according to the instructions for use (ifu).There were no anomalies noted during the prep of the device.It is unknown if there was difficulty advancing the device through the vessel.It is unknown if the device was ever in an acute bend.It is unknown if force was ever required when using the device.The device is available for analysis.

Manufacturer Narrative

Upon further review this complaint does not meet the criteria for medical device reporting since the device outer body was reported to have been separated and not the guidewire lumen.Separation of the outer body is not considered a reportable malfunction.Therefore, this file has been deemed 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: 5447181
• MDR Text Key: 38648115
• Report Number: 9616099-2016-00086
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2018
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 17280877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1