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

Catalog Number ENC453712

Device Problems Premature Activation (1484); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

During stent assisted coil embolization of an 8mm x 10mm anterior communicating artery with a 2.8mm parent artery, the surgeon noted a kink on the proximal end of the prowler select plus microcatheter (606s255x/ 15972546) when the package was opened.The microcatheter was exchanged for a new unspecified brand of microcatheter to complete the procedure, but the enterprise stent (enc453712/ 10306246) did not advance smoothly through the microcatheter due to resistance, and the stent prematurely deployed in the non-codman microcatheter shaft during withdrawal.The surgeon had to remove the microcatheter with the stent.They changed to a new stent and a codman microcatheter to complete the procedure.The devices had been prepped and used as per the instructions for use (ifu), and a continuous flush had been maintained through the microcatheter.There was no report of patient injury or clinically significant delay in the procedure.For the microcatheter that was kinked, it was reported that the packaging had appeared normal the device had been packed securely in the packaging.The devices will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: during stent assisted coil embolization of an 8mm x 10mm anterior communicating artery with a 2.8mm parent artery, the surgeon noted a kink on the proximal end of the prowler select plus microcatheter (606s255x/ 15972546) when the package was opened.The microcatheter was exchanged for a new unspecified brand of microcatheter to complete the procedure, but the enterprise stent (enc453712/ 10306246) did not advance smoothly through the microcatheter due to resistance, and the stent prematurely deployed in the non-codman microcatheter shaft during withdrawal.The surgeon had to remove the microcatheter with the stent.They changed to a new stent and a codman microcatheter to complete the procedure.The devices had been prepped and used as per the instructions for use (ifu), and a continuous flush had been maintained through the microcatheter.There was no report of patient injury or clinically significant delay in the procedure.For the microcatheter that was kinked, it was reported that the packaging had appeared normal the device had been packed securely in the packaging.The devices will be returned for analysis.A non-sterile unit of enterprise eu 4.5x37mm stent 12 mm dw tip was returned for analysis.Inside of the plastic bag, the delivery wire and the introducer tube were received.The involved stent and involved microcatheter were not received for analysis.No anomalies were found during visual analysis.Functional testing could not be performed since the involved stent was not received and the reported failure could not be reproduced in these conditions.The delivery wire was analyzed under vision system, and no anomalies were found.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the above mentioned lot.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 reported enterprise resistance and premature stent deployment were not confirmed since the product could not be properly evaluated since the involved stent was not received and the functional test could not be performed.The cause of the event experienced by the customer could not conclusively determined; however, procedural / handling factors may have contributed to this issue.The device did not present any obvious indications of manufacturing defect or anomaly.The records indicated that the products met specification prior to shipment; therefore no corrective or preventive actions 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: 4873985
• MDR Text Key: 23251581
• Report Number: 1058196-2015-00137
• 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,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: ENC453712
• Device Lot Number: 10306246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR