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 Problems Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  Injury  

Event Description

As reported via the enterprise 2 china study, a (b)(6) male (subject (b)(6)) with a past medical history of grade 2 hypertension, cerebral infarction, cerebrovascular stenosis, carotid arteriosclerosis, peripheral atherosclerosis, thyroid nodule, testing positive for hbsag, hbeab, hbcab and subarachnoid hemorrhage due to a head trauma underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) saccular aneurysm on (b)(6) 2021.Baseline modified rankin score (mrs) was 0- no symptoms at all and hunt-hess grade was 0- unruptured aneurysm.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 5.13mm and neck width 5.13mm.The parent vessel diameter was 3.94mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4.0mm x 23mm enterprise 2 (encr402312/5964699) 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 1: i complete obliteration (no contrast filling in aneurysm body or neck).Before discharge on (b)(6) 2021, the patient¿s modified rankin score (mrs) was 0- no symptoms at all and hunt-hess grade was 0- unruptured aneurysm.On (b)(6) 2022, the patient experienced stenosis of the left middle cerebral artery, which was medically treated, but is still ongoing.The principal investigator assessed this event as mild in severity, non-serious, possibly related to the study device, probably related to the study procedure, and unrelated to the dual antiplatelet therapy.Magnetic resonance angiography (3t-mra) performed on the same day concluded that there was no presence of in-stent thrombosis, rupture or hemorrhage.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Patient identifier: (b)(6) 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.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 (b)(6) male (subject (b)(6)) with a past medical history of grade 2 hypertension, cerebral infarction, cerebrovascular stenosis, carotid arteriosclerosis, peripheral atherosclerosis, thyroid nodule, testing positive for hbsag, hbeab, hbcab and subarachnoid hemorrhage due to a head trauma underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) saccular aneurysm on (b)(6) 2021.Baseline modified rankin score (mrs) was 0- no symptoms at all and hunt-hess grade was 0- unruptured aneurysm.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 5.13mm and neck width 5.13mm.The parent vessel diameter was 3.94mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4.0mm x 23mm enterprise 2 (encr402312/5964699) 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 1: i complete obliteration (no contrast filling in aneurysm body or neck).Before discharge on (b)(6) 2021, the patient¿s modified rankin score (mrs) was 0- no symptoms at all and hunt-hess grade was 0- unruptured aneurysm.On (b)(6) 2022, the patient experienced stenosis of the left middle cerebral artery, which was medically treated, but is still ongoing.The principal investigator assessed this event as mild in severity, non-serious, possibly related to the study device, probably related to the study procedure, and unrelated to the dual antiplatelet therapy.Magnetic resonance angiography (3t-mra) performed on the same day concluded that there was no presence of in-stent thrombosis, rupture or hemorrhage.The stent 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 5964699.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Stenosis of stented segment is a well-known potential adverse event following stent implantation and is listed in the enterprise 2 instructions for use (ifu) as such.Experience with stent implants indicates that there is a risk of stenosis.Patient, procedural, and pharmacological factors may have contributed, however, based on the available information, no conclusion can be made regarding the reported event.Furthermore, the principal investigator reported that the event was possibly related to the study device and probably related to the study procedure.The reported event was assessed as possibly related to the study device, probably related to the study procedure, and required medical intervention.There is no report of a device malfunction or defect.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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).Section b5: additional information was received on 07-jun-2022 indicated that the outcome of the adverse event, stenosis of the left middle cerebral artery, was updated from unknown to not recovered/not resolved.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).Updated sections on this medwatch: b4, b5, g3, g6, h2 and h10.B5: modified information was received on 07-jul-2022 indicated that the relationship with the study procedure was updated from ¿probably related¿ to ¿unlikely related¿ on the crf's.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).Updated sections on this medwatch: b4, b5, g3, g6, h2, h6 and h10.Section b5: additional information was received on 13-feb-2023.Summary of additional information provided: per the clarification received from the clinical research manager, it was confirmed by the investigator and the site, that the location of the target artery was the right side, but the adverse event occurred on the left side.The event had been already reported in medical history (3) and symptoms were not aggravated.Therefore, it was misreporting of the adverse event (ae) ae, and the site inactivated it.This event no longer meets mdr reporting criteria as a ¿serious injury¿.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b3, b4, g3, g6, h2 and h10.Modified information was received on 02-feb-2023.Summary of additional information provided: the onset date for the stenosis was changed from (b)(6) 2022.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 14427898
• MDR Text Key: 291938853
• Report Number: 3008114965-2022-00348
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/22/2023

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: 08/28/2023
• Device Catalogue Number: ENCR402312
• Device Lot Number: 5964699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 07/07/2022; 02/02/2023; 02/08/2023
• Supplement Dates FDA Received: 06/09/2022; 07/18/2022; 02/07/2023; 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: 68 YR
• Patient Sex: Male