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

Catalog Number ENF452200

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: a penumbra benchmark guide, stryker syncro wire, and prowler select plus microcatheter, were used in the procedure.Information regarding patient age, weight and gender were not provided.Complaint conclusion: a non-sterile unit of enterprise vrd and delivery was received inside of a plastic bag.Inside of a box of lot 10398727, part no enf452200 a delivery wire was received with wave conditions observed on distal tip section.The stent and microcatheter involved were not received for analysis.Functional analysis cannot be performed since the stent was not received for analysis.The delivery wire was inspected under vision system and wave conditions were observed on distal tip.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 medicals 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 reported by the customer as the resistance/friction and premature stent deployment could not be evaluated adequately since the stent and microcatheter involved were not received and functional analysis could not be performed.The exact cause of reported event, as well as the wave conditions observed on the microcatheter, could not be conclusively determined.The resistance between the vrd and the microcatheter most likely contributed to the premature stent deployment, but based on the returned product, the cause of the resistance could not be determined.Neither the analysis or dhr suggest that the failure reported could be related to the manufacturing process; therefore, no corrective actions will be taken at this time.This is an initial/final mdr.

Event Description

During distal anterior cerebral artery enterprise placement there was resistance between the enterprise (enf452200/10398727) and the prowler select plus (606s255x/lot unknown), and the stent prematurely deployed in the microcatheter.Initially, a benchmark guide was placed in the right carotid, and a prowler select plus was advanced past the aneurysm location.The enterprise vrd was correctly flushed and placed into the prowler select plus.A continuous flush was maintained through the microcatheter.As the physician advanced the enterprise, he met resistance just after the hub of the microcatheter.He tried to advance the stent through the prowler, but it was difficult to advance.He then pulled back on the delivery wire and it came off the vrd.He used the delivery wire to (push) advance the vrd across the neck of the aneurysm., and retracted the stent delivery wire.He then advanced a coil pusher wire to the proximal vrd end to stabilize it, and retracted the prowler select plus to expose and deploy the vrd.The stent was adequately placed in the desired location with good wall apposition.There were no patient issues or complications, and no clinically significant delay in the procedure.All appropriate flush, prep, and placement protocols were followed.

• 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 ; 5088288310
• MDR Report Key: 4999487
• MDR Text Key: 22844701
• Report Number: 1058196-2015-00162
• 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
• Reporter Occupation: Health Professional
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2016
• Device Catalogue Number: ENF452200
• Device Lot Number: 10398727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1