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 11/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.(b)(4).Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization, the enterprise stent (enc452212/10479604) could not be advanced through the unspecified microcatheter during treatment of an unspecified artery.They withdrew the stent with the microcatheter, and used a new stent to complete the procedure using the same microcatheter.A continuous flush had been maintained through the microcatheter.There was no report of patient injury, and no clinically significant delay in the procedure.The device was returned for analysis.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization, the enterprise stent ((b)(4)) could not be advanced through the unspecified microcatheter during treatment of an unspecified artery.They withdrew the stent with the microcatheter, and used a new stent to complete the procedure using the same microcatheter.A continuous flush had been maintained through the microcatheter.There was no report of patient injury, and no clinically significant delay in the procedure.The device was returned for analysis.The enterprise was returned for analysis.A stent dispenser hoop and stent were received inside of a plastic bag.The stent dispenser hoop was inspected, and it was found without any damages.The stent was received deployed, and no damages were noted.The delivery wire was not returned for evaluation.Functional testing could not be performed since the stent was received deployed and the delivery wire was not returned.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of this complaint involved lot # 10479604.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 within the unspecified microcatheter could not be evaluated since the stent was received deployed and the delivery wire and microcatheter were not returned.The root cause of the event could not be determined; however, the concomitant microcatheter or procedural/handling factors may have contributed to the event.The device did not present any obvious indication of manufacturing defect or anomaly that could have 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: 5443728
• MDR Text Key: 38430262
• Report Number: 1058196-2016-00017
• 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
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: ENC452212
• Device Lot Number: 10479604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1