|
Model Number UNK-NV-ONYX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Event Date 04/23/2019 |
Event Type
Injury
|
Event Description
|
Chin k, leung st, leung kw, kan wk.Management of type ii endoleaks by embolisation after endovascular abdominal aortic aneurysm repair: retrospective review of patient data.Hong kong journal of radiology.2021;24(2):99-107.Doi:10.12809/hkjr2117073.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to review the success and complication rate of transarterial (ta) and translumbar (tl) embolization of type ii endoleaks.A retrospective review of all post-evar type ii endoleaks treated by interventional radiology at the institution was performed from june 2016 to december 2017.Embolization was performed mostly utilizing a transfemoral, and, occasionally, a transbrachial approach, based on the vascular anatomy.A total of 17 embolizations for type ii endoleaks on 11 patients (10 men, 1 woman) with median age 85 years, (range, 71-92 years) were identified.Type iia endoleaks were seen in seven patients: four of them with ima supply and three with la supply.Two patients had more than one intervention for recurrent endoleaks.Three patients with type iib endoleaks from the ima and the la had embolizations performed on the ima alone (n = 1), la alone (n = 1), or both ima and la (n = 1).The last patient had endoleaks supplied by varying numbers of las over time.The procedural success rate was 100%, with angiographic evidence of hemostasis or substantial flow reduction within the aneurysm sac achieved in all 11 patients.The clinical success rate was satisfactory (72%), as eight patients had stable sac size during a median follow-up period of 9.5 months.The results in this group of patients were as follows: reduced or completely resolved endoleak in six patients (75%) and persistent endoleak in two patients (25%).Two patients had an increase in sac size (6-mm and 12-mm increase); one patient received a second embolization, resulting in a stable sac size but a new endoleak with an indeterminate culprit vessel on cta while the other was managed conservatively.The eleventh patient with a 13-cm initial sac size had multiple embolizations performed over 5 months because of persistent endoleaks and sac enlargement.No procedural-related complications were noted the article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted: -two patients had more than one intervention for recurrent endoleaks/increased sac size, only one patient in which onyx was used (11th patient).
|
|
Manufacturer Narrative
|
G2: citation: authors: chin, k., leung, s.T., leung, k.W., <(>&<)> kan, w.K.Management of type ii endoleaks by embolisation after endovascular abdominal aortic aneurysm repair: retrospective review of patient data.Hong kong journal of radiology 24(2):99-107 2021.Doi:10.12809/hkjr2117073.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.
|
|
Search Alerts/Recalls
|
|
|