MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF402300

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint met mdr reporting criteria on 18 oct 2017 when additional information was received indicating that the event resulted in loss of cerebral target position.The enterprise2 was returned for analysis on 10/30/2017; however, the analysis has not yet been completed.(b)(6) 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)(6) 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) and was determined to be acceptable.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs submitted for this complaint with associated report numbers of 3008264254-2017-00147 and 1226348-2017-00182.

Event Description

As reported by a healthcare professional, during treatment of the middle cerebral artery, there was strong resistance when advancing an enterprise device (enf402300/ 10736382) through the prowler select plus (catalog 6062510fx/lot unk) and it was necessary to remove both devices.A continuous flush had been maintained through the microcatheter and there was no vessel tortuosity or calcifications.There were no potential adverse events.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during treatment of the middle cerebral artery, there was strong resistance when advancing an enterprise2 device (enf402300/ 10736382) through the prowler select plus (catalog 6062510fx/lot unk) and it was necessary to remove both devices.A continuous flush had been maintained through the microcatheter and there was no vessel tortuosity or calcifications.There were no potential adverse events.A non-sterile enterprise device was received inside of a pouch.The delivery wire, the introducer tube and the stent were inspected and no obvious damages were noted on them.The received device was inspected under microscope and no damages were noted on it.The functional analysis was performed and the stent could be passed through of the lab sample microcatheter without any difficulty.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of the lot 10736382.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 prowler select plus was not returned for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.The resistance of the enterprise 2 through the prowler select plus was not confirmed.The enterprise device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failure could be related to the enterprise manufacturing process.Procedural factors and handling process may contribute to the failure as reported.There is no current safety signal identified related to the reported event based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 9497899383
• MDR Report Key: 7009489
• MDR Text Key: 92328971
• Report Number: 1226348-2017-00182
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075363
• UDI-Public: (01)10886704075363(17)190828(10)10736382
• 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
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: ENF402300
• Device Lot Number: 10736382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1