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

Catalog Number ENF452812

Device Problem Physical Resistance (2578)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: a micrusphere coil, enterprise stent, orioin.021 microcatheter, sl10 microcatheter and syncro14 wire were used for the procedure (b)(4).Complaint conclusion: the enterprise was not available for analysis.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.Based on the information provided and without films available for review, it is not possible to determine the root cause of the aneurysm rupture, and the partial deployment/protrusion of the coil and resistance between the microcatheter and enterprise cannot be confirmed without product return for analysis.Vessel perforation, hemorrhage and stroke are known procedural complications associated with coil embolization and are listed in the instructions for use as such.Aneurysms have known vessel wall weakness and therefore are susceptible to rupture.Although no definitive conclusion can be made; it is possible that clinical and procedure factors including vessel/aneurysm characteristic contributed to the rupture.Aneurysm characteristics may have also contributed to the coil protrusion from the aneurysm.There was no evidence to suggest that the events were related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is 1 of 2 mdr reports being submitted for this complaint, with associated report number 2954740-2015-00207.This is an initial/final mdr report.

Event Description

During coil embolization of an anterior communicating artery aneurysm, a 2.5 x 3.3 micrusphere (csp10025030 / c17001) was partially deployed into the aneurysm, and while attempting to place an enterprise stent (enf452812/ 10490585), the stent became stuck in the orion.021 microcatheter hub, and the aneurysm ruptured.At this point, all devices, including the partially deployed micrusphere, were removed from the patient, and a balloon was used to tampon the area.The balloon was then removed and the patient was sent to surgery for clipping of the aneurysm.The patient had no symptoms or neurological deficit as a result of the bleed and was being released from the hospital.During the embolization, the micrusphere was the first coil implanted via an sl10 microcatheter.There had been no resistance between the coil and microcatheter and a constant flush had been maintained through the microcatheter.The first two loops of the coil were deployed into the aneurysm, and some of the coil was protruding into the parent vessel, without interruption of blood flow through the artery.The coil did not appear damaged, and the physician kept the initial loops deployed in the aneurysm as a safety measure to keep the microcatheter from perforating the aneurysm dome.After the partial deployment of the micrusphere, the physician decided to stent the neck of the aneurysm with an enterprise stent; however, he did not have the prowler catheter specified in the ifu, and chose to use an off-label orion microcatheter.During insertion of the enterprise into the hub of the microcatheter, the enterprise became stuck and could not be advanced or withdrawn and was withdrawn with the microcatheter.There had been a continuous flush through the microcatheter, and neither the microcatheter or enterprise appeared damaged in any way.At some point during the process, it was believed that the aneurysm bled.The aneurysm had a 2.5mm dome and 2mm neck.A synchro 14 wire and an sl10 mc were also used for the procedure.No additional information was available.

• 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: 5064441
• MDR Text Key: 26500367
• Report Number: 1058196-2015-00175
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Catalogue Number: ENF452812
• Device Lot Number: 10490585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR