Ierardi, a.M., coppola, a., tortora, s., valconi, e., piacentino, f., fontana, f., stellato, e., cogliati, c.B., torzillo, d., giampalma, e., renzulli, m., bargellini, i., cioni, r., scandiffio, r., spinazzola, a., foà, r.A., del giudice, c., venturini, m., <(>&<)> carrafiello, g.(2021).Gastrointestinal bleeding in patients with sars-cov-2 infection managed by interventional radiology.Journal of clinical medicine, 10(20).Https://doi.Org/10.3390/jcm10204758 medtronic review of the literature article found a multicenter retrospective observational study of 34 covid-19 positive patients who were admitted to hospital between january 2020 and march 2021 with acute respiratory symptoms and developed gastrointestinal bleeding (gib).11 patients included in the study underwent embolization with onyx.Other patients underwent embolization with glue or coils but the manufacturer and modelinformation of those devices was not reported in the article.There was no device malfunction or intra-operative issue reported in the article.Technical and clinical success rates were noted to be 88.2% and 94.1%, respectively.It was reported that 5 patients died post-operatively during the study period.Only 1 of the patient deaths was related to hemorrhage.Cause of other patient deaths were not reported in the article.
|
A separate report will be submitted for serious adverse events which did not result in death reported in the literature article.A2.Reported patient age is the median age for all patients included in the study.A3.Reported patient sex is representative of the majority of patients included in the study.A4.Reported patient weight is the median weight from all patients included in the study.B3.Earliest publication date is used for reported event date.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|