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

Catalog Number ENCR402312

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

Patient Problems Thromboembolism (2654); Restenosis (4576)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Patient identifier: (b)(6).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 via the empower study, a (b)(6) female (subject (b)(6)) with a past medical history of hypertension and dizziness underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) aneurysm on (b)(6) 2020.The patient experienced stent thrombosis and stent stenosis on (b)(6) 2021.No action was taken, and the events are resolving.Per the pi, the events were possibly related to the study device, procedure, and dual antiplatelet therapy.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 7.3mm and neck width 5.2mm.The parent vessel diameter was 4.0mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 (encr402312/5832063) vascular reconstruction device (vrd) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure demonstrated raymond-roy score of class 1: complete obliteration.Routine neurological examination performed prior to discharge revealed hunt & hess grade 0 and modified rankin scale (mrs) score of 0.Computed tomography angiography (cta) performed at the 180-day (6 month) follow-up visit on (b)(6) 2021 showed in-stent stenosis (defined as in-stent stenoses (with a stenosis of =33%) of the parent vessel compared to the non-stented portion) and in-stent thrombosis.There was no rupture or hemorrhage noted.Mrs score was 0.Modified raymond-roy classification was class i: complete obliteration.The following medications were started on (b)(6) 2020 for the prevention of thrombosis: atorvastain calcium tablets 20mg by mouth (po) daily, clopidogrel bisulfate tablets 75mg po daily, and aspirin enteric-coated tablets 100mg po daily.The clopidogrel was stopped on (b)(6) 2021 and the aspirin was stopped on (b)(6) 2021.Natracheparin calcium injection was administered intraoperatively for prevention of thrombosis.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, e1, g3, g6, h2, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complain conclusion: as reported via the empower study, a 66-year-old female (subject 01026/r0119) with a past medical history of hypertension and dizziness underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) aneurysm on 15 dec 2020.The patient experienced stent thrombosis and stent stenosis on 21 jul 2021.No action was taken, and the events are resolving.Per the pi, the events were possibly related to the study device, procedure, and dual antiplatelet therapy.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 7.3mm and neck width 5.2mm.The parent vessel diameter was 4.0mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 (encr402312/5832063) vascular reconstruction device (vrd) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure demonstrated raymond-roy score of class 1: complete obliteration.Routine neurological examination performed prior to discharge revealed hunt & hess grade 0 and modified rankin scale (mrs) score of 0.Computed tomography angiography (cta) performed at the 180-day (6 month) follow-up visit on 21 jul 2021 showed in-stent stenosis (defined as in-stent stenoses (with a stenosis of =33%) of the parent vessel compared to the non-stented portion) and in-stent thrombosis.There was no rupture or hemorrhage noted.Mrs score was 0.Modified raymond-roy classification was class i: complete obliteration.The following medications were started on 09 dec 2020 for the prevention of thrombosis: atorvastain calcum tablets 20mg by mouth (po) daily, clopidogrel bisulfate tablets 75mg po daily, and aspirin enteric-coated tablets 100mg po daily.The clopidogrel was stopped on 09 jun 2021 and the aspirin was stopped on 24 jun 2021.Natracheparin calcium injection was administered intraoperatively for prevention of thrombosis.The device remains implanted, therefor, 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 5832063.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Stenosis of the stented segment and stent thrombosis/occlusion are known potential adverse events that may be associated with the use of the enterprise 2 vrd in the intracranial arteries.Experience with stent implants indicates that there is a risk of stenosis.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the stent around the damaged areas.Based on the available information, no definitive conclusion can be made.However, there are patient, procedural, and pharmacological factors that may have contributed.There is no indication of any device performance or manufacturing issues related to the event.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 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 12500598
• MDR Text Key: 282033531
• Report Number: 1226348-2021-00056
• 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,study
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: ENCR402312
• Device Lot Number: 5832063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR