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

Catalog Number ENC402300

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Conclusion: the enterprise 2 was not returned for analysis.(b)(4) 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)(4)'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)(4) and was determined to be acceptable.The resistance between the enterprise 2 and the prowler select plus could not be determined 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.There was no evidence to suggest the vent 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 mdrs submitted for this complaint, with associated reference numbers of 1226348-2016-00137 and 3008264254-2016-00056.

Event Description

As reported by a healthcare professional, during stent assisted coil embolization of a right internal carotid artery aneurysm, the physician used the enterprise 2 (enc402300/10619452); however, he felt strong resistance with the prowler select plus (catalog/lot unk) and the enterprise 2 became stuck.He found that the stent had been deployed at the area of the y connector.The physician eventually removed the microcatheter, retrieved the stent, and continued the procedure.He placed a new enterprise 2 (same size / different lot number) and the procedure was successfully completed without any issue.There was a ten minute delay in the procedure; however, there was 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 times.No visible defect/damage was noted on the products prior to or after the event.The complaint product has already been discarded due to the patient contagious disease and not available for the 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: 5948882
• MDR Text Key: 54645127
• Report Number: 1226348-2016-00137
• Device Sequence Number: 1
• Product Code: NJE
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ENC402300
• Device Lot Number: 10619452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (CATALOG / LOT UNKNOWN)
• Patient Age: 66 YR