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

Model Number ENC452212

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

During treatment of a posterior communicating artery aneurysm, the surgeon noted the enterprise stent (enc452212/ 10380624) could not deployed and the device was removed as a unit with the prowler microcatheter (606s255x, lot unknown), and later in the procedure, a presidio coil (pc410041230/ g13833), stretched during placement in the aneurysm.Aneurysm characteristic information was not available.There was no report of resistance between the enterprise and the prowler during advancement, and a continuous flush had been maintained through the microcatheter.There had been no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the enterprise.The microcatheter had not been re-shaped.The microcatheter was placed distal to the target site prior to advancement of the enterprise to the target site, followed by withdrawal of the catheter to deploy the device.The deployment was then attempted by pushing it out of the end of the catheter.It is unknown if, or how many times, the device had been recaptured.The enterprise was partially deployed out of the microcatheter.The procedure was continued with another device after the enterprise and prowler were removed from the patient.

Manufacturer Narrative

Then when the physician advanced the second coil into the aneurysm, a presidio, he noted that the coil had partly stretched.The microcatheter used at the time was unknown; however, a continuous flush had been maintained, and there was no resistance between the coil and microcatheter.It was unknown if the microcatheter was repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter, but a one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning the coil.There was no report of coil entanglement.There was no additional intervention required, and the coil was removed as a unit with the microcatheter with the coil still attached to the delivery system.Another coil was used to continue the procedure.There was no report of patient injury or a clinically significant delay in the procedure due to the enterprise and presidio events.The devices are not available for analysis.(b)(4).This device met mdr reportability criteria on november 19, 2014 when information provided indicated that there was loss of target position related to the event; additional information will be submitted within 30 days of receipt.This is 1 of 3 mdrs submitted for this complaint with associated manufacture report numbers of 1058196-2014-00287, 1058196-2014-00288, and 2954740-2014-50041.

Manufacturer Narrative

During treatment of a posterior communicating artery aneurysm, the surgeon noted the enterprise stent (enc452212/ 10380624) could not be deployed, and the device was removed as a unit with the prowler microcatheter (606s255x, lot unknown).Later in the procedure, a presidio coil (pc410041230/ g13833) stretched during placement in the aneurysm.Aneurysm characteristic information was not available.There was no report of resistance between the enterprise and the prowler during advancement, and a continuous flush had been maintained through the microcatheter.There had been no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the enterprise.The microcatheter had not been re-shaped.The microcatheter was placed distal to the target site prior to advancement of the enterprise to the target site, followed by withdrawal of the catheter to deploy the device.The deployment was then attempted by pushing it out of the end of the catheter.It is unknown if, or how many times, the device had been recaptured.The enterprise was partially deployed out of the microcatheter.The procedure was continued with another device after the enterprise and prowler were removed from the patient.Then when the physician advanced the second coil into the aneurysm, a presidio, he noted that the coil had partly stretched.The microcatheter used at the time was unknown; however, a continuous flush had been maintained, and there was no resistance between the coil and microcatheter.It was unknown if the microcatheter was repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter, but a one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning the coil.There was no report of coil entanglement.There was no additional intervention required, and the coil was removed as a unit with the microcatheter with the coil still attached to the delivery system.Another coil was used to continue the procedure.There was no report of patient injury or a clinically significant delay in the procedure due to the enterprise and presidio events.The device was not available for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10380624.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 inability to deploy the enterprise though the prowler microcatheter and the presidio coil stretching could not be confirmed without product return for analysis.It is not possible to determine the root cause of the failure; however, procedural/handling factors may have contributed to the events.The enterprise instructions for use (ifu) cautions not to recapture the stent more than once.The ifu also instructs ¿if stent positioning is satisfactory, carefully retract the infusion catheter, while maintaining the position of the delivery wire, to allow the stent to deploy across the neck of the aneurysm.The stent will expand as it exits the infusion catheter.The presidio ifu cautions ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.There was no evidence of a manufacturing issue related to the events reported; therefore, no corrective actions will be taken at this time.This is 1 of 3 mdrs submitted for this complaint with associated manufacture report numbers of 1058196-2014-00287, 1058196-2014-00288, and 2954740-2014-50041.

• 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: 4261323
• MDR Text Key: 5105017
• Report Number: 1058196-2014-00288
• 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,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: ENC452212
• Device Catalogue Number: ENC452212
• Device Lot Number: 10380624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS MICROCATHETER
• Patient Age: 48 YR
• Patient Weight: 67