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

Catalog Number ENC452800

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

During vrd-assisted coil embolization of a 5mm right internal carotid-posterior communicating artery aneurysm, it was reported that when inserting the enterprise vrd (enc452800/10483050) into the prowler select plus (606-s255fx/17146825), the physician experienced a severe resistance at about 10cm from the proximal end of the microcatheter.The prowler was replaced with a str-angled prowler (lot unknown) and the enterprise was re-inserted, but the physician again experienced a severe resistance at the same point.The enterprise was removed from the microcatheter and was replaced with an enterprise 22mm (lot unknown), which was successfully placed at the target lesion site with the same microcatheter.When the event occurred, the guide catheter had been positioned at the proximal side of the internal carotid artery, and a j-shaped prowler had also been inserted and positioned at about 5cm proximally from the target aneurysm.Since the tortuosity of the vessels was mild, the delivery of the complaint prowler was smooth.The procedure was completed without further issues.There were no patient injuries/complications.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all times.No visible damage was noted on the products prior to the event.There was no unintended detachment of the stent observed in the microcatheter.The aneurysm neck to sac ratio was 4.5 : 5.0mm.The complaint products will be returned for analysis.No further information is available.

Manufacturer Narrative

Concomitant products: a sheath introducer by terumo (model unknown), a chikai (asahi intecc, 0.014¿), an envoy (7fr mpc, lot unknown), a transform (stryker, 4x10), an enterprise vrd (enc452800 / 10483050), a prowler select plus (606-s255fx / 17146825), and a y-connector by goodman (model unknown) were used for this procedure.The device has been returned for analysis; however, the analysis has not yet been completed.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.(b)(4).Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs submitted for this complaint, with associated report numbers 1058196-2015-00131 and 1058196-2015-00130.

Manufacturer Narrative

Complaint conclusion: during vrd-assisted coil embolization of a 5mm right internal carotid-posterior communicating artery aneurysm, it was reported that when inserting the enterprise vrd (enc452800/10483050) into the prowler select plus (606-s255fx/17146825), the physician experienced a severe resistance at about 10cm from the proximal end of the microcatheter.The prowler was replaced with a str-angled prowler (lot unknown) and the enterprise was re-inserted, but the physician again experienced a severe resistance at the same point.The enterprise was removed from the microcatheter and was replaced with an enterprise 22mm (lot unknown), which was successfully placed at the target lesion site with the same microcatheter.When the event occurred, the guide catheter had been positioned at the proximal side of the internal carotid artery, and a j-shaped prowler had also been inserted and positioned at about 5cm proximally from the target aneurysm.Since the tortuosity of the vessels was mild, the delivery of the complaint prowler was smooth.The procedure was completed without further issues.There were no patient injuries/complications.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all times.No visible damage was noted on the products prior to the event.There was no unintended detachment of the stent observed in the microcatheter.The aneurysm neck to sac ratio was 4.5 : 5.0mm.No further information was available.A non-sterile unit of enterprise was returned for analysis.Inside of the plastic bag the delivery wire was received and the involved stent was received deployed.No anomalies were found during visual analysis.Functional test could not be performed since the involved stent was received deployed and the reported failure could not be reproduced in these conditions.The stent was analyzed under vision system and no anomalies were found during 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 felt within the prowler was confirmed during the functional test; however, no anomalies were noted on the enterprise.The cause of the failure experienced by the customer appears was due to the kinked condition found on the microcatheter.The kinked condition was apparently caused by applying excessive force, but it could not be conclusively determined.However this defect could not be related to the manufacturing process and inspections are in place that prevents this kind of failure from leaving from the manufacturing facility.Procedural factors appear to have contributed to have this damage.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; therefore, no corrective action will be taken at this time.This is 1 of 2 mdrs submitted for this complaint, with associated report numbers 1058196-2015-00131 and 1058196-2015-00130.

• 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: 4861924
• MDR Text Key: 5848648
• Report Number: 1058196-2015-00130
• 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,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• 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: ENC452800
• Device Lot Number: 10483050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2015
• 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
• Patient Age: 85 YR