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

Catalog Number ENF402312

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.Information about patient age, weight and gender are not available.This is 1 of 2 mdr reports being submitted for this complaint with associated report numbers of 1226348-2017-00168 and 3008264254-2017-00134.

Event Description

A technician reported that the physician had trouble advancing the enterprise2 (enf402312/ 10803890) through the prowler select plus (606s255fx/ 17707076).It was reported that the physician had been well trained and proper technique and flush were used.He removed both devices and placed another prowler select plus in the aneurysm and deployed another enterprise 2 without incident.No patient injuries or complications arose due to the first stent failure to deploy.The event delayed the procedure for 10 minutes.

Manufacturer Narrative

Conclusion: a technician reported that the physician had trouble advancing the enterprise (enf402312/ 10803890) through the prowler select plus (606s255fx/ 17707076).It was reported that the physician had been well trained and proper technique and flush were used.He removed both devices and placed another prowler select plus in the aneurysm and deployed another enterprise 2 without incident.No patient injuries or complications arose due to the first stent failure to deploy.The event delayed the procedure for 10 minutes.A non-sterile enterprise was received coiled inside of a pouch.The enterprise was received stuck into microcatheter.Compressed sections in distal end tip of the microcatheter were noted.The enterprise stuck into the microcatheter was inspected under x-ray (microscopic analysis); the stent could be observed stuck into the microcatheter due to compressed sections.The functional test could not be performed due to the condition of the received device.The delivery wire could not be withdrawal from the microcatheter due to the compressed sections on body of the microcatheter.(b)(4) reviewed the device history records relative to the manufacturing, inspecting and packaging of this complaint involved lot # 10803890.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) 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 enterprise stuck in the microcatheter was confirmed.The cause of the event appears to have been due to the compressed condition on the microcatheter received.Neither the product analysis nor the dhr review suggests that the failure could be related to the enterprise manufacturing process.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 1 of 2 mdr reports being submitted for this complaint with associated report numbers of 1226348-2017-00168 and 3008264254-2017-00134.

• 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: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 9497899383
• MDR Report Key: 6921835
• MDR Text Key: 89518805
• Report Number: 1226348-2017-00168
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: (01)10886704075356(17)200128(10)10803890
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: ENF402312
• Device Lot Number: 10803890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1