MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401612

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

Patient Problems Nausea (1970); Vomiting (2144); Ischemia Stroke (4418)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The event was reported via the icad study in china.The 59-year-old male patient underwent the vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.The patient reported nausea and vomiting on (b)(6) 2022; the nausea was mild in severity.It was determined that the nausea and vomiting was not related to the study device, but possibly related to the study procedure.The nausea and vomiting resolved on (b)(6) 2022 without sequelae.On 21-oct-2022, modified information was received.The information indicated that the patient experienced a mild subcutaneous hemorrhage on (b)(6) 2022 at an undisclosed location and a lacunar cerebral infarction on (b)(6) 2022.The investigator stated that the hemorrhage is not related to the study device but is related to the procedure and the infarction is possibly not related to the device but is possibly related to the procedure.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.This event was discussed with the medical safety officer (mso) on 10-nov-2022.Given the 2-days interval between procedure and the reported event, the relationship between the enterprise 2 device and cerebral infarction cannot be excluded.Cerebral infarction is a known potential adverse event associated with the use of the enterprise 2 device and is listed in the instructions for use (ifu) as such.There are patient, procedural, and pharmacological factors that may have contributed with no indication of a device malfunction or defect.There is no medical evidence to indicate that the reported event was related to the device.However, the relationship between the enterprise 2 device and the reported event of ¿cerebral infarction¿ cannot be excluded.Therefore, the event will be conservatively reported to the fda with the 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.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

Event was reported via the icad study in china.The 59-year-old male patient underwent the vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.The patient reported nausea and vomiting on (b)(6) 2022; the nausea was mild in severity.It was determined that the nausea and vomiting was not related to the study device, but possibly related to the study procedure.The nausea and vomiting resolved on (b)(6) 2022 without sequelae.On 21-oct-2022, modified information was received.The information indicated that the patient experienced a mild subcutaneous hemorrhage on (b)(6) 2022 at an undisclosed location and a lacunar cerebral infarction on (b)(6) 2022.The investigator stated that the hemorrhage is not related to the study device but is related to the procedure and the infarction is possibly not related to the device but is possibly related to the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[additional information]: on 15-nov-2022, additional information was received that included the facility name and address.The information also included the product code and device lot number: 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401612 /6920556).The patient had no accompanying symptoms.On 25-nov-2022, the following modified information was received.The start date of the adverse event is 27-jul-2022.The surgery date is (b)(6) 2022.The adverse event term is mild haemorrhage subcutaneous (right inguinal region).Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6920556.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: ENTERPRISE2 4MMX16MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15785192
• MDR Text Key: 303566196
• Report Number: 3008114965-2022-00744
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401612
• Device Lot Number: 6920556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: 59 YR
• Patient Sex: Male