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

Catalog Number UNKENTERPRISEENF

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/30/2014

Event Type  Injury  

Event Description

It was reported that a physician was asked by a fellow physician in another city if the delivery wire of the enterprise stent (unknown catalog and lot) was mri compatible because his patient had part of the wire broken off in his head.No one is aware of the physician or hospital where the stent may have been placed other than it was somewhere in michigan.The person that covers michigan was contacted and no reports of this nature were reported.There is a possibility that device might be a neuroform instead of an enterprise, however with no further information or direct contact with the physician requesting the information, the event could not be corroborated.

Manufacturer Narrative

The device was not returned for analysis, and the lot number was not provided to conduct dhr.With the information available and without the product available for analysis the complaint could not be confirmed.Inspections are in place to prevent damaged products from leaving the facility.No corrective action is required at this time.It is difficult to draw a clinical conclusion between the device and the event based on the limited information available.However, there are possible procedural factors, specifically the tip reshaping and additional torque applied that may have contributed to the events.The product captured in section represents an enterprise with unknown catalog and lot number.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3635304
• MDR Text Key: 3989236
• Report Number: 1058196-2014-00044
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening