MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

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

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

Dzieciuchowicz, l., tomczak, j., strauss, e., oszkinis, g.Mid-term results of endovascular aneurysm sealing in the treatment of abdominal aortic aneurysm with unfavorable morphology.Vascular and endovascular surgery.2021.Vol.55(1) 39-49.Doi: 10.1177/1538574420965736.Summary: to report mid-term results of endovascular aneurysm sealing (evas) of abdominal aortic aneurysms (aaa) deemed unsuitable for a standard endovascular aneurysm repair (evar).Methods: a prospectively maintained database of 42 patients with evar-unfavorable anatomy treated by evas combined with chimney grafts in case of the proximal aaa neck shorter than 5 mm was analyzed.Early outcomes included final angiographic result, intra- and early post-operative deaths, and complications.Mid-term outcomes included all-cause mortality (acm), aneurysm-related mortality (arm), patency of the stents, occurrence of endoleaks, serious complications and graft failures defined as the aaa growth of more than 5 mm, type i endoleak, occlusion of the stent-graft or chimney graft, aorto-duodenal fistula, or aneurysm rupture.The procedure was completed in all patients.Twenty-eight chimney grafts were implanted in 19 patients.Patients were followed for a median of 24 months (range 12-34 months).There were 2 intraoperative ruptures and 1 patient died in an early postoperative period.The cumulative acm was 15, 21, and 36% at 12, 24, and 36 months, respectively, and the cumulative arm was 8, 11, and 27% at 12, 24, and 36 months, respectively.Three out of 5 aneurysm-related deaths were due to a secondary aorto-duodenal fistula.The cumulative incidence of graft failure was 20, 27, and 42% at 12, 24, and 36 months, respectively.The cumulative incidence of an endoleak was 5, 9, and 23% at 12, 24, and 36 months, respectively.The graft failure increased significantly both acm (p ¼.012) and arm (p ¼.00003).The implantation of chimney grafts at the initial procedure increased arm significantly (p ¼.008).The presence of an endoleak did not have any significant influence on acm and arm.Patients treated with evas for aaas with evar-unfavorable anatomy, especially those with chimney grafts, exhibit a high risk of graft failure and subsequent death.Reported events: during the follow-up, 6 endoleaks in 5 patients were diagnosed, 4 ia at 2, 17, 31, and 36 months, and 2 ib at 5 and 27 months after the implantation.Two type ia endoleaks occurred in patients with chimney grafts and 2 in patients without chimney grafts.Among the patients with the type ia endoleak 2 patients required conversion to an open repair (one after an unsuccessful endovascular intervention and one due to a coexisting aorto-duodenal fistula), one had embolization with onyx, and one refused treatment and is under observation.Both type ib endoleaks were treated with a distal stent-graft extension.

Manufacturer Narrative

No specific device information provided.See attached literature article.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.

Event Description

Additional information received reported that medtronic is not the manufacturer of any products indicated in the mentioned article.

Manufacturer Narrative

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.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17612714
• MDR Text Key: 321848463
• Report Number: 2029214-2023-01479
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/09/2023
• 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): Required Intervention