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

Catalog Number ENC402300

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

During treatment of an 80% stenosis in the right internal carotid artery in the passage to m1, after an enterprise 2 (enc402300/ 10495632) was advanced 2/3 of the way through the prowler select plus (606s255fx/ 17116018), it could not be pushed or pulled further, and the entire system had to be removed from the patient.There was a 45 - 60 minute delay in the procedure due to the strong elongation of the patient vessels; however, there were no adverse events to the patient.The devices were stored as per the labeling instructions, and appeared normal prior to use.The devices were prepped as per the instructions for use (ifu) and the enterprise had been placed securely in the hub of the microcatheter prior to advancement.The devices did not appear damaged after removal from the patient, and the microcatheter had not been bent during the procedure.The devices will be returned for analysis.

Manufacturer Narrative

It is anticipated that the device will be returned for analysis; however, the device has not yet been returned for analysis.(b)(4).Additional information will be submitted within 30 days of receipt.This is 1 of 2 devices associated with this complaint with associated report numbers of 1226348-2015-00002 and 1058196-2015-00119.

Manufacturer Narrative

Complaint conclusion: during treatment of an (b)(4) stenosis in the right internal carotid artery in the passage to m1, after an enterprise 2 ((b)(4)) was advanced 2/3 of the way through the prowler select plus ((b)(4)), it could not be pushed or pulled further, and the entire system had to be removed from the patient.There was a 45 - 60 minute delay in the procedure due to the strong elongation of the patient vessels; however, there were no adverse events to the patient.The devices were stored as per the labeling instructions, and appeared normal prior to use.The devices were prepped as per the instructions for use (ifu) and the enterprise had been placed securely in the hub of the microcatheter prior to advancement.The devices did not appear damaged after removal from the patient, and the microcatheter had not been bent during the procedure.One non-sterile enterprise2 4mmx23mm no tip stent and delivery wire, along with a prowler sel plus 150/5cm 45tip device were received for analysis coiled inside a plastic bag.Per visual analysis, the delivery wire was received inserted inside the microcatheter.The microcatheter was found kinked at 127.3 cm from proximal end of hub and compressed from 0.5cm to 3.5 cm from the distal end tip.The compressed section was 3.0 cm in length.No other components from the enterprise system were received.No other anomalies were observed.The prowler sel plus 150/5cm 45tip microcatheter was inspected under x-ray (microscopic analysis) and the enterprise stent could be observed stuck within due to compressed microcatheter condition.Functional testing was attempted with no success.The delivery wire could not be moved whether back or forward through the microcatheter due to the kinked/compressed condition of the microcatheter.(b)(6) medical reviewed the device history records relative to the manufacturing, inspecting and packaging of (b)(6) lr packaging l/n 10495632.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)(6) 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 (b)(6) medical and was determined to be acceptable.The enterprise being impeded and unable to be advanced or withdrawn was confirmed during the microscope analysis since the delivery wire could not be moved whether back or forward through the microcatheter due to the confirmed kinked/compressed condition of the prowler select plus microcatheter.The failure experienced by the customer and the damages found on the device could not be conclusively determined; however, procedural/handling factors may have contributed to the event.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally, inspections are in place that prevents these kinds of failures from leaving from the manufacturing facility.Therefore no corrective action will be taken at this time.This is 1 of 2 devices associated with this complaint with associated report numbers of 1226348-2015-00002 and 1058196-2015-00119.(b)(4).

• 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 ; 325 paramount dr; raynham, MA 02767 ; 5088288310
• MDR Report Key: 4821029
• MDR Text Key: 18632066
• Report Number: 1226348-2015-00002
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: ENC402300
• Device Lot Number: 10495632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (606S255FX/ 17116018)
• Patient Age: 46 YR
• Patient Weight: 60