MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF402312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Patient identifier: (b)(6).The lot number 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 via the (b)(6) study, a (b)(6) female (subject (b)(6)) with a past medical history of hypertension and a broken finger underwent stent-assisted coil embolization of an unruptured wide-necked posterior communicating artery aneurysm on (b)(6) 2020 and experienced mild intracranial aneurysm recurrence on (b)(6) 2021.The aneurysm recurrence resolved with repeat embolization and oral medication.Per the principal investigator (pi), the event was not likely related to the study device or procedure and not related to dual antiplatelet therapy.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 5.91mm and neck width 5.94mm.The parent vessel diameter was 3.31mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 encr402312/unknown lot number) vascular reconstruction device (vrd) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure raymond-roy score was class i: complete obliteration.Routine neurological examination performed prior to discharge on (b)(6) 2020 demonstrated hunt & hess grade 0 and modified rankin scale (mrs) score of 0.Digital subtraction angiography (dsa) performed on (b)(6) 2021 showed raymond-roy score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of aneurysm rupture/hemorrhage, in-stent stenosis, or in-stent thrombosis.Routine neurological examination was normal.Mrs and hunt & hess scores were 0.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: per the pi, the event was mild in severity and not related to the study device, procedure, or dual antiplatelet therapy.The event resolved on (b)(6) 2021.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 18 may 2021 indicated that the lot number of the enterprise 2 vrd was 11188145.Competitor coils were implanted in the aneurysm during the initial study procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete with 100% occlusion.The aneurysm occlusion was 90% at the time of recanalization diagnosis.The enterprise stent was patent and covering the aneurysm neck.The competitor coils remained within the aneurysm sac; however, there was evidence of coil compaction.The pi felt that the aneurysm recanalization was caused by the patient¿s poor vascular condition.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the enterprise 2 china study, a 67-year-old female (subject 09001/r0901) with a past medical history of hypertension and a broken finger underwent stent-assisted coil embolization of an unruptured wide-necked posterior communicating artery aneurysm on (b)(6) 2020 and experienced mild intracranial aneurysm recurrence on (b)(6) 2021.The aneurysm recurrence resolved with repeat embolization and oral medication.Per the principal investigator (pi), the event was not likely related to the study device or procedure and not related to dual antiplatelet therapy.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 5.91mm and neck width 5.94mm.The parent vessel diameter was 3.31mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 (encr402312/unknown lot number) vascular reconstruction device (vrd) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure raymond-roy score was class i: complete obliteration.Routine neurological examination performed prior to discharge on (b)(6) 2020 demonstrated hunt & hess grade 0 and modified rankin scale (mrs) score of 0.Digital subtraction angiography (dsa) performed on (b)(6) 2021 showed raymond-roy score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of aneurysm rupture/hemorrhage, in-stent stenosis, or in-stent thrombosis.Routine neurological examination was normal.Mrs and hunt & hess scores were 0.Modified information received indicated that per the pi, the event was mild in severity and not related to the study device, procedure, or dual antiplatelet therapy.The lot number of the enterprise 2 vrd was 11188145.Competitor coils were implanted in the aneurysm during the initial study procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete with 100% occlusion.The aneurysm occlusion was 90% at the time of recanalization diagnosis.The enterprise stent was patent and covering the aneurysm neck.The competitor coils remained within the aneurysm sac; however, there was evidence of coil compaction.The pi felt that the aneurysm recanalization was caused by the patient¿s poor vascular condition.The device was not returned as it remains implanted.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11188145.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Aneurysm recanalization is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device (vrd) in the intracranial arteries and is listed in the instructions for use (ifu) as such.Review of the available information does not allow for an exact determination of root cause; however, factors which may have a correlation with recanalization following coil embolization include neck size, packing density, and inflow angle.There was no indication of any device performance or manufacturing issues associated with the enterprise vrd.The investigator reported that the recanalization was secondary to the patent¿s poor vascular condition.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.

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.Modified information received on 11 apr 2022 was reviewed.The onset date of the event was changed from 29 mar 2021 to 23 mar 2021.

• Brand Name: ENTERPRISE2 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11685560
• MDR Text Key: 262550749
• Report Number: 1226348-2021-00023
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: 10886704075356
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: ENF402312
• Device Catalogue Number: ENCR402312
• Device Lot Number: 11188145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female