MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

Patient Problem Stenosis (2263)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).[conclusion]: as reported via the empower study, a 50-year-old female patient with a history of right internal carotid ocular segment aneurysm underwent stent-assisted coil embolization an unruptured wide-necked internal carotid artery (ica) saccular aneurysm on (b)(6) 2021.The saccular aneurysm had the following dimensions: maximum aneurysm diameter of 4.1mm and neck width of 3.5mm.The parent vessel diameter was 3.6mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 stent (encr402312 / 6322169) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.The immediate post-procedure assessment showed raymond-roy's score of class i: complete obliteration.A routine neurological examination performed prior to discharge on (b)(6) 2021 revealed a hunt & hess grade 0 and a modified rankin scale (mrs) score of 0.A 30-day follow-up visit was performed via phone on (b)(6) 2021.The digital subtraction angiography (dsa) examination was planned for 180 days after surgery.The 180-day follow-up performed on (b)(6) 2021 revealed a modified rankin scale (mrs) score of 0, a hunt & hess grade 0, and a raymond-roy's score of class i: complete obliteration.Dsa performed on that day showed no signs of rupture, hemorrhage, in-stent stenosis, or in stent thrombosis.The patient¿s one (1) year follow-up was performed on (b)(6) 2022.During this visit, the patient answered ¿yes¿ to whether in-stent thrombosis had occurred.The routine neurological examination was normal, with a modified rankin scale (mrs) score of 0, a hunt & hess grade of 0, and raymond-roy's score of class i: complete obliteration.However, dsa performed on that same day showed suspected stent stenosis.The principal investigator assessed this event as mild in severity, not serious, and possibly related to the study device, the study procedure, and the dual antiplatelet therapy.The event is resolving, and the patient is recovering.The patient was not treated for the event.On 01-aug-2022, additional information was received.The information indicated that ¿it cannot be determined whether the in stent restenosis was = 50% is due to unclear image imaging.¿ no action was taken for the in-stent restenosis.The patient was asymptomatic for the suspected in-stent restenosis.The patient was previously compliant with aspirin and atorvastatin.Regarding the current status of the patient, there was no obvious abnormal adverse symptom.The patient¿s condition will be continuously monitored.Based on complaint information, the enterprise stent remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6322169.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Stenosis is a known complication associated with the use of the enterprise 2 vascular reconstruction device and is mentioned in the instructions for use (ifu) as such.The device performed as intended and no new patient consequences have occurred related to the use of the device.The reported outcome is not related to the device.However, the principal investigator assessed the event of suspected stent stenosis as possibly related to the study device and the study procedure.Therefore, this event is considered serious and mdr reportable.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

As reported via the empower study, a 50-year-old female patient with a history of right internal carotid ocular segment aneurysm underwent stent-assisted coil embolization an unruptured wide-necked internal carotid artery (ica) saccular aneurysm on (b)(6) 2021.The saccular aneurysm had the following dimensions: maximum aneurysm diameter of 4.1mm and neck width of 3.5mm.The parent vessel diameter was 3.6mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 stent (encr402312 / 6322169) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.The immediate post-procedure assessment showed raymond-roy's score of class i: complete obliteration.A routine neurological examination performed prior to discharge on (b)(6) 2021 revealed a hunt & hess grade 0 and a modified rankin scale (mrs) score of 0.A 30-day follow-up visit was performed via phone on (b)(6) 2021.The digital subtraction angiography (dsa) examination was planned for 180 days after surgery.The 180-day follow-up performed on (b)(6) 2021 revealed a modified rankin scale (mrs) score of 0, a hunt & hess grade 0, and a raymond-roy's score of class i: complete obliteration.Dsa performed on that day showed no signs of rupture, hemorrhage, in-stent stenosis, or in stent thrombosis.The patient¿s one (1) year follow-up was performed on (b)(6) 2022.During this visit, the patient answered ¿yes¿ to whether in-stent thrombosis had occurred.The routine neurological examination was normal, with a modified rankin scale (mrs) score of 0, a hunt & hess grade of 0, and raymond-roy's score of class i: complete obliteration.However, dsa performed on that same day showed suspected stent stenosis.The principal investigator assessed this event as mild in severity, not serious, and possibly related to the study device, the study procedure, and the dual antiplatelet therapy.The event is resolving, and the patient is recovering.The patient was not treated for the event.On 01-aug-2022, additional information was received.The information indicated that ¿it cannot be determined whether the in stent restenosis was = 50% is due to unclear image imaging.¿ no action was taken for the in-stent restenosis.The patient was asymptomatic for the suspected in-stent restenosis.The patient was previously compliant with aspirin and atorvastatin.Regarding the current status of the patient, there was no obvious abnormal adverse symptom.The patient¿s condition will be continuously monitored.

• Brand Name: ENTERPRISE2 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15184536
• MDR Text Key: 297447857
• Report Number: 3008114965-2022-00516
• Device Sequence Number: 1
• Product Code: NJE
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6322169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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): Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female