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

Catalog Number ENC452812

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

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 device is expected for return but has not yet been returned.A supplemental report will be submitted with additional information if the product is returned.

Event Description

The contact from the facility reported that the front wire of the enterprise stent (enc452812/10566055) broke inside the patient¿s body.At the time of the initial contact, the device was available for return.

Manufacturer Narrative

Three attempts to obtain additional information regarding the event were unsuccessful.Conclusion: the contact from the facility reported that the front wire of the enterprise stent (enc452812/10566055) broke inside the patient¿s body.No additional information could be obtained from the customer.A non-sterile enterprise device was received inside of a plastic bag.The introducer tube and the stent were not returned for evaluation.The delivery wire was inspected and the distal tip was not returned for evaluation.The distal section of the device was inspected under microscope, and the edge of broken section shows evidence that the distal tip was kinked before it was broken.Also, the delivery wire was found stretched.(b)(4) reviewed the device history records relative to the manufacturing, inspecting and packaging of the lot 10566055.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 wire separation was confirmed since the distal tip of the delivery wire was separated and not returned for evaluation.The distal section of the device was inspected under microscope, and the edge of the fractured section showed evidence that the distal tip was kinked before it was broken.The broken section found on the device was apparently caused by applying excessive force on the devices, but it could not be conclusively determined.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failure could be related to the enterprise manufacturing process; procedural factors and handling process may contribute to the failure as reported.No corrective action will be taken at this time.

• 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: 6327662
• MDR Text Key: 67335541
• Report Number: 1226348-2017-00013
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704043997
• UDI-Public: (01)10886704043997(17)170628(10)10566055
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Catalogue Number: ENC452812
• Device Lot Number: 10566055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1