MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF401612

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The product lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, while trying to deploy a 4mmx16mm enterprise 2 stent (enf401612, unknown lot) at a lesion in the arteria communicans anterior (a-com), the stent deployed in competitor's microcatheter (mc) unexpectedly.The surgeon removed the whole system and used new stent delivery system with a prowler select plus microcatheter 45 degrees.The procedure was finished normally.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, while trying to deploy a 4mmx16mm enterprise2 stent (enf401612, unknown lot) at a lesion in the arteria communicans anterior (a-com), the stent deployed in competitor's microcatheter (mc) unexpectedly.The surgeon removed the whole system and used new stent delivery system with a prowler select plus microcatheter 45 degrees.The procedure was finished normally.There was no patient injury reported.The device was returned for analysis and therefore no further investigation can be performed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.With the limited information available and without the product available for analysis, the reported customer complaint of ¿stent - deployment difficulty-premature/in microcatheter¿ could not be confirmed.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Of note, the device was being used off-label to treat carotid artery stenosis.According to the ifu, the enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE2 4MMX16MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9304628
• MDR Text Key: 203491055
• Report Number: 1226348-2019-01019
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075332
• UDI-Public: 10886704075332
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENF401612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MICROCATHETER