Catalog Number ENCR401612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Vomiting (2144); Ischemia Stroke (4418)
|
Event Date 10/11/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter facility name, address, and the name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the event was reported via the icad study in china.The 74-year-old female patient underwent the vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.The patient experienced vomiting on (b)(6) 2022.The principal investigator (pi) assessed the vomiting to be mild in severity, possibly related to the procedure and not related to the study device.The vomiting event resolved without sequelae on (b)(6) 2022.On 27-oct-2022, modified additional information was received.The information indicated that the patient experienced a new onset brain infarction on (b)(6) 2022 in an unknown brain territory.The principal investigator (pi) assessed the event to be mild in severity.The new onset infarction event was definitively assessed as related to the procedure and is still ongoing.There were no report of any device deficiencies.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 (b)(6) 2022.Given the 2-day interval between procedure and the reported event, the relationship between the enterprise ii 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.The device performed as intended, 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
|
The event was reported via the icad study in china.The 74-year-old female patient underwent the vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.The patient experienced vomiting on (b)(6) 2022.The principal investigator (pi) assessed the vomiting to be mild in severity, possibly related to the procedure and not related to the study device.The vomiting event resolved without sequelae on (b)(6) 2022.On (b)(6) 2022, modified additional information was received.The information indicated that the patient experienced a new onset brain infarction on (b)(6) 2022 in an unknown brain territory.The principal investigator (pi) assessed the event to be mild in severity.The new onset infarction event was definitively assessed as related to the procedure and is still ongoing.There were no report of any device deficiencies.
|
|
Manufacturer Narrative
|
Manufacturer¿s ref.No: (b)(6).The purpose of this mdr submission is to include the additional event information received on (b)(6)2022.[additional information]: on (b)(6) 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 procedure date was confirmed to be (b)(6) 2022.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.Updated sections: b.4, d.1, d.4, e.1, g.3, g.6, h.2, h.4, h.6, 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.
|
|
Search Alerts/Recalls
|
|