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 Problems Hematoma (1884); Paresis (1998); Numbness (2415); Cerebral Edema (4403); Unspecified Nervous System Problem (4426)

Event Date 10/01/2006

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-onyx (); g2: citation: authors: strauss i, frolov v, buchbut d, gonen l, maimon s.Critical appraisal of endovascular treatment of brain arteriovenous malformation using onyx in a series of 92 consecutive patients.Acta neurochir 155:611¿617 2013.10.1007/s00701-013-1633-0.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.

Event Description

The introduction of onyx has led us to adopt a new treatment approach for brain arteriovenous malformation (avm), using endovascular embolization with onyx as the first line treatment with a curative intent.The aim of the present report is to evaluate our results using this strategy, with special emphasis on angiographic characteristics affecting treatment risks and success rates.From october 2006 to december 2009, 92 consecutive patients harboring brain avm were treated with onyx during 177 procedures.Endovascular treatments were completed in 68 out of 92 patients.Median number of procedures was two.Complete obliteration using embolization exclusively was achieved in 25 patients, resulting in a 37 % cure rate in patients who concluded treatments (25/68), and 27 % in the cohort.In spetzler-martin grades 1 / 2 avms, complete obliteration was achieved in 48 % of the cases.Complete obliteration rates were significantly higher in lesions with superficial big feeding arteries.There were 15 bleeding complications during 177 embolization sessions (8.4 % per procedure); seven cases resolved in less than 3 months.Permanent disability rate was 6.5 %; mortality rate was 2.2 %.Bleeding was related to the use of the microcatheter/guidewire in six cases and to the use of the embolization material in nine, the amount of onyx injected was significantly higher in those nine cases.Embolization of brain avm using onyx and detachable tip microcatheters results in a relatively high rate of complete obliteration.A ngioarchitecture of the lesion can predict treatment success.Higher amounts of onyx injected per session increase the bleeding risk.    adverse events included: 1.Postoperative bleedings 2.Mild peri-procedural neurological deficits 3.Hematomas 4.Thalamic hematoma 5.Mild hypoesthesia 6.Postoperative hemiparesis 7.Poor neurological state 8.Death.

• 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: 17560627
• MDR Text Key: 321309716
• Report Number: 2029214-2023-01413
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 08/16/2023

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?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/16/2023
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male