MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 10/01/2022

Event Type  Injury  

Event Description

The event was reported via the icad study in china.The 73-year-old male patient underwent a vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.The patient experienced cognitive dysfunction on an unknown date in (b)(6) 2022.The reported cognitive was assessed by the investigator as mild in severity, not serious, possibly unrelated to the study device, possibly unrelated to the surgery, and not an unanticipated adverse device effect (uade).The patient did not receive medication, non-drug therapy, or in-patient surgery to treat the reported event.The cognitive dysfunction did not result to the patient requiring in-patient hospitalization or prolonged in-patient hospitalization, there was no permanent impairment in body function / structure.The event is noted to be persistent with the outcome value ¿symptoms persist.¿ the end date value is ¿blank.¿ the device remains implanted.There was no reported device deficiency.There was no ischemic stroke or symptomatic cerebral hemorrhage reported in relation to the event.On (b)(6) 2023, additional information was received from the clinical research team.The information indicated that the cognitive dysfunction was confirmed during the follow-up visit and judged through computed tomography angiography (cta) imaging.¿since this adverse event (ae) cannot completely exclude the relationship of device and procedure, so the relationship was judged as unlikely.¿ the cta was performed six months after the procedure and will be further confirmed by digital subtraction angiography which will be performed one year after the procedure.

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 initial reporter facility name, address, and the name, phone and email address of the initial reporter are not available / reported.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.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Neurological deficit is a known potential complication associated with the use of the enterprise2 vascular reconstruction device and is listed in the instructions for use (ifu) as such.There were no alleged device malfunctions or performance issues associated with the enterprise2 stent.Nevertheless, per information received assessment the event was classified as possibly unrelated to the study device and possibly unrelated to the surgery.This complaint was discussed with the medical safety officer (mso) on (b)(6) 2023, and even though the device performed as intended with no reported malfunction, the event will be conservatively reported to the fda 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.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 modified additional information received on 12-may-2023.[additional information]: on 12-may-2023, the following modified information was received: date of record is updated from 30-mar-2023 to 12-may-2023.Relationship to study related device was updated from ¿possibly unrelated¿ to ¿unrelated¿ and the field ¿if other, please describe:¿ field was updated from ¿a visit to the neurology department is recommended¿ to ¿referral to a neurologist is recommended.¿ updated sections: b.4, g.3, g.6, h.2, and h.10.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: UNKENTERPRISE2
• 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: 16825233
• MDR Text Key: 314112253
• Report Number: 3008114965-2023-00268
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male