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

Catalog Number ENF452212

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Three attempts to obtain information have been unsuccessful.The device has not yet been returned 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.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs being submitted for this event, with associated report numbers of 1226348-2016-00058 and 1058196-2016-00071.

Event Description

As reported by a healthcare professional, an enterprise stent ((b)(4)/10480746) became stuck in the prowler select plus (b)(4) during advancement of the stent through the microcatheter.Both devices were removed from the patient.There were no potential adverse events.

Manufacturer Narrative

Additional information was received on 5/2/2016: the event occurred during treatment of the middle cerebral artery.There was no known cause of the enterprise becoming stuck in the prowler select plus, and a continuous flush had been maintained through the microcatheter.The devices appeared normal prior to use and neither device appeared damaged after removal from the patient.The devices had been used and prepped as per the ifu.The stent did not prematurely deploy during the procedure and had become stuck in the main shaft of the microcatheter.The devices were removed without difficulty and did not result in patient injury or a clinically significant delay in the procedure.Information about patient age, weight gender and medical history could not be provided.It was initially reported that the devices would be returned for analysis; however, after multiple attempts to obtain the products, the products were not returned.Conclusion: as reported by a healthcare professional, during treatment of the middle cerebral artery, an enterprise stent ( enf452212/10480746) became stuck in the prowler select plus (606s255fx/ 17289402) during advancement of the stent through the microcatheter.A continuous flush had been maintained through the microcatheter, and the devices appeared normal prior to use.Neither device appeared damaged after removal from the patient.The devices had been used and prepped as per the instructions for use (ifu).The stent did not prematurely deploy during the procedure and had become stuck in the main shaft of the microcatheter.The devices were removed without difficulty and did not result in patient injury or a clinically significant delay in the procedure.It was reported that the devices would be returned for analysis; however, after multiple attempts to obtain the product for analysis, no product was returned.The enterprise was not returned for analysis.(b)(4) 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 (b)(4) internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at (b)(4) and was determined to be acceptable.The event of the enterprise becoming stuck in the prowler select plus could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural factors may have contributed to the event.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is 1 of 2 mdrs being submitted for this event, with associated report numbers of 1226348-2016-00058 and 1058196-2016-00071.

Manufacturer Narrative

The device was returned for analysis on 6/13/2016.Conclusion: as reported by a healthcare professional, during treatment of the middle cerebral artery, an enterprise stent (enf452212/10480746) became stuck in the prowler select plus (606s255fx/ 17289402) during advancement of the stent through the microcatheter.A continuous flush had been maintained through the microcatheter, and the devices appeared normal prior to use.Neither device appeared damaged after removal from the patient.The devices had been used and prepped as per the instructions for use (ifu).The stent did not prematurely deploy during the procedure and had become stuck in the main shaft of the microcatheter.The devices were removed without difficulty and did not result in patient injury or a clinically significant delay in the procedure.A non-sterile enterprise device was received inside of a plastic bag.The deliver wire was received coiled, and no damages were noted.The introducer tube was not received for evaluation.The stent was received deployed, and no damages were noted on it.The received stent was inspected under microscope and no damages were noted.The functional analysis could not be performed since the stent was not received and it is necessary that the stent is still inside of the introducer tube to perform the functional 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.The resistance between the enterprise and prowler select plus microcatheter could not be confirmed for the enterprise since the device could not be evaluated with the stent deployed.The prowler select plus being impeded was not confirmed; however resistance was confirmed.The resistance could not be conclusively determined; however, appears to be due to the kink and compressed sections found on the device.Neither the product analysis nor the dhr review suggests that the failure could be related to the manufacturing process; therefore, no corrective action will be taken at this time.This is 1 of 2 mdrs being submitted for this event, with associated report numbers of 1226348-2016-00058 and 1058196-2016-00071.

• 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: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 5576252
• MDR Text Key: 42748607
• Report Number: 1226348-2016-00058
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• 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: ENF452212
• Device Lot Number: 10480746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1