MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401600

Device Problem Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device remains implanted; therefore, no further investigation can be performed.(b)(4) did review the device history records relative to the manufacturing, inspecting and packaging of the lot 5876388.The history records indicate this product was final inspection tested at (b)(4) and was determined to be acceptable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported by (b)(6) that a (b)(6) male patient underwent stent-assisted coil embolization of a basilar tip aneurysm on (b)(6) 2020 with a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600/5876388) and experienced aneurysm recurrence secondary to stent displacement on (b)(6) 2021.The patient subsequently underwent repeat embolization of the basilar tip aneurysm on (b)(6) 2021.The operation went smoothly.Immediate post-procedure raymond-roy classification score was class i: complete obliteration.The user report stated the following: ¿it is evaluated that there is a reasonable time sequence between the occurrence of this sae and the use of research instruments, and the causal relationship between the event and the use / operation and test operation of research instruments cannot be excluded.Therefore, it is judged that the relationship between the sae and the use of research instruments/surgery, and the test operation is likely to be related.¿ the device is not available for evaluation.No further information was provided.

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: it was reported by the china health authority (nmpa) that a 30-year-old male patient underwent stent-assisted coil embolization of a basilar tip aneurysm on 30-oct-2020 with a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600/5876388) and experienced aneurysm recurrence secondary to stent displacement on (b)(6) 2021.The patient subsequently underwent repeat embolization of the basilar tip aneurysm on (b)(6)2021.The operation went smoothly.Immediate post-procedure raymond-roy classification score was class i: complete obliteration.The user report stated the following: ¿it is evaluated that there is a reasonable time sequence between the occurrence of this sae and the use of research instruments, and the causal relationship between the event and the use / operation and test operation of research instruments cannot be excluded.Therefore, it is judged that the relationship between the sae and the use of research instruments/surgery, and the test operation is likely to be related.¿ the device is not available for evaluation.No further information is available.The device remains implanted; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 5876388.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Stent migration and aneurysm recanalization are known potential adverse events that may be associated with the use of the enterprise 2 vrd in the intracranial arteries.With the amount of information available and without imaging/films, it is not possible to determine the root cause of the event.However, there are patient and procedural factors that may have contributed to the event rather than the design or manufacture of the device.The alleged stent migration with consequent aneurysm recurrence necessitated surgical intervention to preclude permanent impairment.The file will be re-reviewed if additional information is received at a later date.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 NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 12704140
• MDR Text Key: 281751766
• Report Number: 1226348-2021-00099
• Device Sequence Number: 1
• Product Code: NJE
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: ENCR401600
• Device Lot Number: 5876388
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR