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

Catalog Number ENC452812

Device Problem Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

During stent assisted coil embolization of the m2 segment of the left middle cerebral artery aneurysm, when the physician was advancing a enterprise vrd (enc452812/10233429) in an unspecified prowler select plus microcatheter (catalog and lot unknown), the enterprise got stuck at the distal end of the prowler select plus.As no portion of the enterprise was exposed from the microcatheter tip, both the enterprise vrd and the microcatheter were safely removed as a unit from the patient, and the enterprise vrd was replaced for a new product (enc452812, lot unknown).The stent did not prematurely deploy during the procedure.It is unknown if the microcatheter was replaced or not.Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.No information regarding the implanted coils was provided.During the procedure, jailed technique and trans-cell technique were utilized.The unruptured aneurysm neck was 6.0mm, and the neck to sac ratio was 6.0mm:12.0mm.The parent vessel size diameter proximal was 3.6mm and distally was 2.8mm/3.1mm.The complaint product was new and stored per labeling instruction.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.The complaint product is going to be returned for evaluation.No additional information is available and procedural images are not available.

Manufacturer Narrative

(b)(6).Concomitant medication: antiplatelet therapy included aspirin 100mg/day: (b)(6) 2014~ongoing, clopidogrel sulfate 75mg/day: (b)(6) 2014~ongoing, heparin 4000u was administered intra-procedurally.Complaint conclusion: one non-sterile enterprise vrd and delivery was received coiled in a plastic bag.The unit was inspected and no damages/anomalies were found.The stent was found already deployed (outside introducer tube).Coil tip and stent were observed under microscope magnification.No damages/anomalies were found.Functional test was performed.Enterprise (without stent) was inserted and advanced through a microcatheter.No resistance / friction was felt.Note: a microcatheter lab sample had to be used on this test since involved microcatheter was not returned for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10233429.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 failure reported by the customer as the enterprise becoming stuck in the prowler select plus microcatheter was not confirmed and could not be conclusively evaluated since the stent was already deployed (outside introducer) and the microcatheter was not returned for analysis.Analysis and dhr review indicates that the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.The cause of the event experienced by the customer could not be determined; it is possible that procedural factors or handling may have contributed with the reported condition since the records indicated that the product met specification prior shipment.Since there was no evidence of a manufacturing issue, no corrective actions will be taken.This is 1 of 2 devices associated with this complaint with associated manufacture report numbers: 1058196-2014-00139 and 1058196-2014-00140.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3798971
• MDR Text Key: 17161349
• Report Number: 1058196-2014-00140
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: ENC452812
• Device Lot Number: 10233429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR