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 10/13/2014

Event Type  malfunction  

Event Description

The surgeon felt friction between the enterprise stent ((b)(4)/lot unknown) and the prowler select plus microcatheter (details unknown) during advancement.The surgeon chose an envoy 6f guide catheter (details unknown) and a prowler select plus microcatheter to establish access.The surgeon positioned 2 coils (details unknown) smoothly.When he advanced the stent he felt much friction.The surgeon had to remove the stent and microcatheter as a unit and changed to another stent (details unknown) along with 4 coils (details unknown) to complete the surgery.The patient is fine now.No adverse event was reported.The device did not kink or bend at any time prior to the resistance/friction.The concomitant devices used with the product did not kink or bend at any time.When the device was removed from the patient there were no damages on any part of the device.An adequate continuous flush was maintained through the catheter.The introducer was fully seated and secured in the catheter hub during introduction of the device into the catheter.

Manufacturer Narrative

The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.(b)(4).

Manufacturer Narrative

A non-sterile unit of enterprise vascular reconstruction device and delivery system was received inside of its original pouch package.Inside of the pouch the delivery wire was received inside of a coil dispenser and the involved stent was received deployed.Also the involved microcatheter was not received for analysis.No anomalies were found during visual analysis.The functional test could not be performed since the stent involved was received deployed.In order to perform the test it is required that the stent be mounted on the delivery wire.Stent was analyzed under vision system and no anomalies were found.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10361575.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 reported failure by the customer that friction was felt when advancing the stent through the microcatheter could not be confirmed since the functional test could not be performed and the failure could not be reproduced due to the stent was received deployed.The cause of the event experienced by the customer could not be conclusively determined.However, procedural / handling factors might have contributed to those issues.The device did not present any obvious indications of manufacturing defect or anomaly.The records indicated that the product met specification prior to shipment; therefore no corrective or preventive actions 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: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4249276
• MDR Text Key: 17294233
• Report Number: 1058196-2014-00283
• 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: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 47 YR