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 Insufficient Information (4580)

Event Date 09/15/2023

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id unk-nv-marathon (unknown); implant date: n/a; explant date: n/a, product id: unk-nv-onyx (unknown); implant date n/a; explant date n/a, product id: unk-nv-marathon (unknown); implant date n/a; explant date n/a.G2: citation: authors: alfter, m., albiña-palmarola, p., cimpoca, a., díaz-peregrino, r., jans, p., ganslandt, o., kühne, d., <(>&<)> henkes, h.Multi-stage treatment for spetzler¿martin grades iii, iv, and v arteriovenous malformations: preoperative embolization and microsurgical resection in a consecutive series of 250 patients.Journal of clinical medicine 12(18):5990 2023.Doi:10.3390/jcm12185990 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.

Event Description

Alfter m, albiña-palmarola p, cimpoca a, et al.Multi-stage treatment for spetzler¿martin grades iii, iv, and v arteriovenous malformations: preoperative embolization and microsurgical resection in a consecutive series of 250 patients.Journal of clinical medicine.2023;12(18):5990.Doi:10.3390/jcm12185990 medtronic literature review found a report of patient complications in association with onyx liquid embolic and marathon catheters.The purpose of this article was to present the authors¿ experience spanning three decades of treatment of high-grade arteriovenous malformations (avms) by using a multi-stage approach consisting of preoperative embolization and subsequent microsurgical resection, and to investigate factors potentially associated with safety and effectiveness outcomes.A total of 250 patients were included, consisting of 109 females (43.6%) and 141 males (56.4%).The mean age was 56.26 years.All patients included in this study received preoperative embolization and subsequent surgical resection.Onyx was used in 18.4% of the cases.It is unknown how many cases involved a marathon catheter.The article does not state any technical issues during use of the onyx or marathon.The following intra- or post-procedural outcomes were noted:  - the overall mortality rate after follow-up was 3.6% (nine cases).It was noted that no patients died after embolization, and four patients died after surgery.

• 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: 18728135
• MDR Text Key: 335691646
• Report Number: 2029214-2024-00309
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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?: Yes
• Date Manufacturer Received: 02/08/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Death
• Patient Age: 56 YR