MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number ENC452212

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the stent-assisted coil embolization of a posterior communicating artery aneurysm, resistance was felt when the enterprise stent (enc452212/ 10512789) was advanced to a1 section opening.They withdrew the stent with the unspecified microcatheter, and changed to a new enterprise stent (enc452212/ 10512789), but the 2nd stent could not be deployed after it was advanced to the lesion location.They withdrew the 2nd stent and used a new one to complete the procedure.It was reported that a continuous flush had been maintained through the microcatheter.The stents did not appear damaged during the procedure and neither of the stents had prematurely deployed.The devices were prepped and used as per the instructions for use.There was no report of patient injury, and the events did not result in a clinically significant delay in the procedure.It was reported that the devices would be returned for analysis.

Manufacturer Narrative

This mdr is being submitted to provide the udi number.(b)(4).Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Device was returned for analysis on 1/14/2016; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported by a healthcare professional, during stent-assisted coil embolization of a posterior communicating artery aneurysm, resistance was felt when the enterprise stent (enc452212/ 10512789) was advanced to a1 section opening.They withdrew the stent with the unspecified microcatheter, and changed to a new enterprise stent (enc452212/ 10512789), but the 2nd stent could not be deployed after it was advanced to the lesion location.They withdrew the 2nd stent and used a new one to complete the procedure.It was reported that a continuous flush had been maintained through the microcatheter.The stents did not appear damaged during the procedure, and neither of the stents had prematurely deployed.The devices were prepped and used as per the instructions for use.There was no report of patient injury, and the events did not result in a clinically significant delay in the procedure.A non-sterile enterprise device was received inside of a plastic bag.The stent was found deployed.The introducer tube and the deliver wire were received in the same plastic bag and no damages were noted on them.The stent was inspected under microscope, and no damages were noted.The functional analysis could not be performed since the stent was received deployed, and it is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the lot 10512789.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 first enterprise and the microcatheter that resulted in loss of microcatheter target position, and the inability to deploy the second enterprise stent could not be confirmed since the stents were received deployed, and was not inside the introducer tube.The root cause of the events could not be determined; however, procedural factors or the concomitant microcatheter may have contributed to the events.The devices 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; therefore, no corrective action will be taken at this time.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 5350393
• MDR Text Key: 35262199
• Report Number: 1058196-2016-00006
• Device Sequence Number: 1
• Product Code: NJE
• 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,Followup,Followup,Followup
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: ENC452212
• Device Lot Number: 10512789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR