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

Catalog Number ENC403900

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer name could not be provided.Customer phone: (b)(6).Conclusion: the device was not available for analysis.(b)(6) 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 (b)(6) 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 (b)(6) medical and was determined to be acceptable.The resistance between the enterprise 2 and the unspecified microcatheter and the delivery wire kink could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the event.It appears that the physician continued to push the device after resistance was met.The instructions for use warns ¿do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.¿ there is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization of an internal carotid artery aneurysm, there was strong resistance when an enterprise 2 vrd (enc403900/ 10566053) was inserted into the proximal part of an unspecified microcatheter, and when the physician attempted to push the device, the delivery wire kinked.Therefore, the micro catheter was removed from the patient and the enterprise 2 vrd was not deployed.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The product was not available for investigation.No further information was available.

• 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: 6838780
• MDR Text Key: 84967809
• Report Number: 1226348-2017-00141
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075240
• UDI-Public: (01)10886704075240(17)180610(10)10566053
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2018
• Device Catalogue Number: ENC403900
• Device Lot Number: 10566053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1