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 Hemorrhage/Bleeding (1888); Ischemia (1942); Muscle Weakness (1967); Cognitive Changes (2551); Swelling/ Edema (4577)

Event Date 08/01/2005

Event Type  Injury  

Event Description

The purpose of the article was to report experience using onyx in pediatric patients for a variety of cranial and spinal vascular lesions and tumors to determine its procedural complication rates, types, and clinical consequences and to highlight the indications for and principles of onyx embolization in pediatric patients.All pediatric onyx embolization cases performed consecutively by the neuroendovascular services at our 2 institutions over a 5-year period were collected retrospectively and analyzed.Over the study period, 105 onyx embolization procedures were performed in 69 pediatric patients with a mean follow-up of 112 days.Fifty-two patients harbored ¿primary¿ vascular lesions (malformations, fistulas, etc), whereas 17 patients had tumors.Complications occurred in 25 of 105 procedures (23.8%) and included ischemic infarct (7), asymptomatic nontarget embolization (4), intracerebral hemorrhage (3), microcatheter-related vessel perforation (3), retained microcatheter (2), cerebral edema (2), dimethyl sulfoxide-induced pulmonary edema (2), facial ischemia (1), and contrastinduced bronchospasm (1).Neurological morbidity occurred transiently after 10 procedures (9.5%) and permanently after 2 procedures (1.9%).There were no procedurerelated deaths.Statistical analysis revealed no predictors of complications among the multiple potential risk factors evaluated.The experience suggests that onyx can be used effectively for embolization of pediatric cranial and spinal vascular lesions and tumors with low permanent morbidity; however, attention must be paid to the technical nuances of and indications for its use to avoid potential complications   adverse events included: 1.Ischemic infarct 2.Intracerebral/intraventricular hemorrhage 3.Perilesional cerebral edema 4.Pulmonary edema 5.Facial ischemia (ischemic bruise) 6.Extremity weakness 7.Cognitive abnormalities.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id unk-nv-onyx (); product type: ; implant date ; explant date g2: citation: authors: ashour r, aziz-sultan ma, soltanolkotabi m, schoeneman s, alden t, hurley m, dipatri a, tomita t, elhammady m, shaibani a.Safety and efficacy of onyx embolization for pediatric cranial and spinal vascular lesions and tumors.Neurosurgery 71:773¿784 2012.10.1227/neu.0b013e3182648db6 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.

• 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: 17560134
• MDR Text Key: 321323979
• Report Number: 2029214-2023-01409
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/18/2023
• 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: 10 YR
• Patient Sex: Male