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

Catalog Number ENC452200

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that during treatment of an unruptured middle cerebral artery (mca) aneurysm and normal vessel the enterprise stent (enc452200/lot # unknown) could not be placed accurately during deployment.The stent was not implanted at an acute angle, and upon deployment, the stent ¿jumped back¿ 10mm beyond its intended site.To place the stent, the microcatheter was placed distal to the target site, then withdrawn to deploy the device.The device could not be recaptured, removed, or relocated.The stent was implanted in the mca ¿ internal carotid artery (ica) junction with good wall apposition.There was no vessel stenosis.A prowler select plus (details unknown) microcatheter was used in the procedure.The procedure was completed with embolic coils (details unknown) and there was no issue passing other devices through the same microcatheter.An adequate continuous flush was maintained through the catheter.The microcatheter was not reshaped.There was no difficulty during introduction of the microcatheter over the guidewire prior to attempted use of the stent.There was no patient injury or significant clinical delay in the procedure due to the issue.At initial contact the product was not available for return.

Manufacturer Narrative

No sterile lot number was reported thus no dhr could be conducted.Stent migration is a known potential adverse event associated with intravascular stent implantation and is listed in the enterprise ifu as such.All products are 100% inspected prior to leaving the manufacturing facility and there is no evidence of a manufacturing related issue.No corrective action is required at this time.Review of the limited information suggests that vessel, target site and procedural issues may have contributed to the reported event.Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.

• 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: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4602030
• MDR Text Key: 20119935
• Report Number: 1058196-2015-00062
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1