MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE 2 4MM X 23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCI402312

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

Patient Problem Restenosis (4576)

Event Date 01/26/2024

Event Type  Injury  

Event Description

The event was reported via the icad study in china.The 32-year-old female patient underwent a vascular stent placement procedure using an enterprise 2 stent (catalog / lot# unknown) on (b)(6) 2023.On (b)(6) 2024, the patient experienced the event of ¿post arterial stenting restenosis of left brain.¿ the principal investigator (pi) assessed the event as moderate in severity, possibly related to the study device, and possibly unrelated to the surgical procedure.The reported event was not an unanticipated adverse device effect (uade).The event was not medically treated, however, ¿surgery is recommended.¿ the event was not classified as a symptomatic cerebral hemorrhage or ischemic stroke, nor did the event result in prolonged hospitalization, fatal illness/injury, or permanent impairment of body structure/body function.There was no device deficiency, and the device remains implanted for continued use.The outcome is recorded as ¿symptoms ongoing,¿ with persistent symptoms.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section e.1: the initial reporter facility name and address are not available.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.There was no intra-operative device performance issue or device malfunction reported during the procedure.Arterial re-stenosis of a stented segment is a known potential complication associated with the use of the enterprise2 stent and is listed in the instructions for use (ifu) as such.There were no alleged quality issues regarding the used device, as the device performed as intended and no new patient consequences have occurred because of the used device.The pi assessed this event as possibly related to the study device and possibly unrelated to the surgical procedure.Section 4.10 of the clinical evaluation report (cer) for the medical device states the therapeutic lifetime of the enterprise stent is one year.Although there may have been patient and pharmacological factors that contributed to the event, the correlating relationship of the event to the device cannot be ruled out, as the event occurred approximately 347 days after the procedure, within the therapeutic lifetime of the device.Additionally, the severity of the event is unknown, as symptoms are reported to be ongoing, and a surgical treatment was recommended.Therefore, the event of ¿post arterial stenting restenosis of left brain¿ meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ 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 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 803.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 09-apr-2024.[additional information]: on 09-apr-2024, additional information was received.Per the information, the patient completed a 12-month post-operative follow-up at (b)(6) university.The study device was a 4mm x 23mm enterprise 2 (enci402312 / 6920558).The patient had not undergone further surgery.¿the patient¿s follow-up from enrollment to 12-month after the procedure is asymptomatic.¿ lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 6920558.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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.

• Brand Name: ENTERPRISE 2 4MM X 23MM
• 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 ; 303552-689
• MDR Report Key: 19068237
• MDR Text Key: 339681709
• Report Number: 3008114965-2024-00345
• 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,Followup
• Report Date: 04/17/2024

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 Catalogue Number: ENCI402312
• Device Lot Number: 6920558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/17/2024
• 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: 32 YR
• Patient Sex: Female