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

Catalog Number ENC452212

Device Problems Positioning Failure (1158); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that the physician felt much resistance advancing the enterprise stent (enc452212/10364513) through the prowler select plus (6062510x/lot unknown) microcatheter during stent-assisted embolization of the left carotid ophthalmic aneurysm.Although the stent reached to the target lesion it could not be deployed when the delivery wire was withdrawn.The surgeon removed the stent and its delivery wire and changed to a new stent and microcatheter to complete.There was no report on patient injury.Upon initial contact the enterprise was available for return.The prowler select plus is not available for return.There was no significant clinical delay due to the issue.Nothing unusual about the device was reported prior to use.An adequate continuous flush was maintained through the catheter.There was no difficulty introducing the microcatheter over the guidewire prior to the attempted use of the device.No other device went through the same microcatheter.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 deployment of the device was attempted by pushing it out of the end of the microcatheter.The device had not been recaptured.

Manufacturer Narrative

The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.The manufacture and expiration dates are being researched and will be provided with the supplemental report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A non sterile enterprise vrd was received inside of a non cordis guide wire packaging pouch and this was inside of the original enterprise packaging pouch.The enterprise was received inserted in the introducer tube.The enterprise stent was received already deployed.The involved microcatheter was not received.No anomalies were observed on the received unit.The enterprise stent was observed under a microscope and it presented no damages or anomalies.No functional analysis could be performed as the involved microcatheter was not received and the enterprise stent was received already deployed.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10364513.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.The failure that the stent prematurely deployed in the microcatheter hub reported by the customer could not be confirmed; the failure that there was resistance/friction through the microcatheter could not be properly evaluated as no functional test could be performed because the stent was received already deployed.The exact cause of the events experienced by the customer could not be conclusively determined.However, procedural/handling factors appear to have impacted on the failure experienced by the customer.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failures could be related to the enterprise manufacturing process; therefore, no corrective action will be taken at this time.

• 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: 4383105
• MDR Text Key: 5128215
• Report Number: 1058196-2015-00002
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: ENC452212
• Device Lot Number: 10364513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Date Device Manufactured: 02/20/2014
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (6062510X/LOT UNKNOWN)