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 Hematoma (1884); Restenosis (4576)

Event Date 09/07/2023

Event Type  Injury  

Event Description

As reported via the icad study in china, a 46-year-old male patient (b)(6) who underwent vascular stent placement with an unknown enterprise ii vascular reconstruction device on (b)(6) 2022.On (b)(6) 2023, the patient experienced the event of ¿restenosis of the right middle cerebral artery after stenting¿.The principal investigator assessed this event as moderate in severity, not serious, and unrelated to the surgery.The relationship of the event to the study device was recorded as ¿blank¿.Whether the event was related to a device deficiency, the answer was recorded as ¿blank¿.The device remains implanted in the patient for continued use.The event did not require medication treatment, prolonged hospitalization, nor an inpatient surgery.Symptoms are said to be persistent.The outcome of the event was ¿ongoing symptoms¿ with an end date of ¿blank¿.Additional information was received on 26-sep-2023.Summary of the information provided: regarding the event of ¿restenosis of the right middle cerebral artery after stenting¿, the pi assessed this event as moderate in severity, not serious, and possibly unrelated to the study device and unrelated to the surgery.There were no device deficiencies related to the event.Symptoms remain to be persistent.The additional information received on 26-sep-2023 has been reviewed.The pi¿s assessment of the event, ¿restenosis of the right middle cerebral artery after stenting¿ was updated as being possibly unrelated to the study device and unrelated to the study procedure.

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1 - patient identifier: (b)(6).Section d3 ¿ the product catalog and lot numbers were not reported, udi unavailable.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Per the additional information received on 14-sep-2023, restenosis after stenting is a known potential complication associated with the use of the enterprise ii vascular reconstruction device and is listed in the instructions for use (ifu) under neurological deficit and stenosis of the stented segment.There were no reported device performance issues/malfunctions related to the device, as the device performed as intended.There may have been patient and pharmacological contributing factors, such as the adherence to anticoagulation medications, with no indication of device malfunction.The event was assessed by the pi as not serious, unrelated to the surgical procedure, and the relationship to the study device was not disclosed.Regarding the event of ¿restenosis of the right middle cerebral artery after stenting¿, the event occurred within the one-year therapeutic device lifetime of the enterprise ii vascular reconstruction device.Additionally, the severity of the event is unknown, and symptoms are reported to be ongoing.Therefore, the event of ¿restenosis of the right middle cerebral artery after stenting¿ does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury¿, with an awareness date of 14-sep-2023.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Manufacturer Narrative

Product complaint (b)(4).Additional information was received on 18-oct-2023.Summary: per the additional information, the product code and lot number for the enterprise stent was provided: product code: enci402312, lot number: 6920558.The device remains implanted; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical 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.

• 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17860609
• MDR Text Key: 324798310
• Report Number: 3008114965-2023-00709
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6920558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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: 46 YR
• Patient Sex: Male