MAUDE Adverse Event Report: CORDIS NEUROVASCULAR ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Model Number N/A

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

The surgeon felt friction when he advanced the enterprise stent (enc451412/10324295) through the microcatheter (details unknown) during embolization of a posterior communicating artery aneurysm.The surgeon tried out of the patient¿s body but still had same issue.The surgeon changed to a new microcatheter but still failed.Finally the surgeon changed new stent to complete.No adverse event on the patient.

Manufacturer Narrative

(b)(4).Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10324295.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the information, the event could not be confirmed.The product was not returned for analysis; however, a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

Manufacturer Narrative

Additional information: the microcatheter was exchanged over a guidewire, retaining target position.There was no clinically significant delay in the procedure due to the issue.An adequate continuous flush was maintained through the catheter.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the device.There was no difficulty tracking the microcatheter to the target site prior to introduction of the stent.There were no kinks on the microcatheter before or after the difficulty.After further information was received, the event does not meet criteria for medwatch reporting as there was no loss in target vessel position.Therefore, please note that no further information will be forthcoming for this report.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CORDIS NEUROVASCULAR; 14700 nw 57th court; miami lakes FL
• Manufacturer Contact: kipp durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4153724
• MDR Text Key: 4766383
• Report Number: 1058196-2014-00256
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: N/A
• Device Catalogue Number: ENC451412
• Device Lot Number: 10324295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (DETAILS UNKNOWN)