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

Catalog Number ENF453712

Device Problems Material Discolored (1170); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Manufacturer Narrative

The root cause of the event could not be confirmed because the device will not be returned for analysis.The sterile lot number was not provided therefore a device history record review could not be performed.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).

Event Description

The contact from the facility reported that during a procedure to treat a vertebral artery dissection, the enterprise stent (enf453712/lot unknown) could not be visualized after attempting to deploy.During the procedure the catheter was placed distal to the target site prior to advancement of the device to the target site followed by withdrawal of the catheter to deploy the device.The stent had not been recaptured.It is unknown whether the stent was placed.There was no tactile response indicating that the stent was deployed.After placement of a velocity microcatheter (details unknown) across the dissection area, an attempt was made to insert the enterprise stent into catheter without success.The velocity microcatheter was exchanged for a prowler select plus microcatheter (606s255x/16077303.) once the prowler was placed across the area of dissection the enterprise stent delivery device was inserted without difficulty through the prowler into position at the area of dissection.A deployment maneuver was completed without visualization of stent in the vertebral artery.Several contrast runs as well as multiple fluoroscopic projection failed to visualize any stent.The introducer sheath of the enterprise and both microcatheters were vigorously examined for the stent without evidence of one present.The patient continued to show improvement and the procedure was terminated.There was an adequate continuous flush maintained through both microcatheters used in the procedure.A guiding catheter (details unknown), sheath (details unknown), guidewire (details unknown were also used in the procedure.Nothing unusual was noted about the system prior to use.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 5244648
• MDR Text Key: 31981274
• Report Number: 1058196-2015-00207
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENF453712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1