MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Conclusion: the enterprise stent was not returned for analysis.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 resistance between the enterprise stent and the prowler select plus could not be confirmed without product return for analysis.The root cause of the event could not be determined without product analysis and based on the information provided.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 2 mdr reports submitted for this event, with associated report numbers of 3008264254-2017-00032 and 1226348-2017-00021.

Event Description

During the stent assisted coil embolization, the enterprise stent (enc452212/10706768) could not be advanced via the prowler select plus microcatheter (606s255x/17524799).They withdrew and exchanged the stent with microcatheter, but the 2nd enterprise stent (enc452212/10706768) could not deploy through the replacement microcatheter and the stent was withdrawn from the second microcatheter without loss of target position.There was no damage noted to the stent or the microcatheter, and a continuous flush had been maintained through the microcatheter.The stent had been positioned at the target site, but was not partially deployed.There were no known factors as to why the deployment failure occurred.They used another stent to complete the procedure.There was no report of patient injury, and the procedure was delayed less than 30 minutes.All devices had been prepped and used as per the ifu.As the patient has hepatitis, the products had been discarded.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 6394982
• MDR Text Key: 69850555
• Report Number: 1226348-2017-00021
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704043980
• UDI-Public: (01)10886704043980(17)180628(10)10706768
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: ENC452212
• Device Lot Number: 10706768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (606S255X/17524799)
• Patient Age: 52 YR