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 Muscle Weakness (1967); Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Rupture (2208); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

See attachments for 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

Kent r.Richter, reed a.Richter, christoph griessenauer, edward a.Monaco; cureus; 2022; 14(2); glioblastoma adjacent to radiosurgically treated arteriovenous malformation: a case report and review of the literature; doi: 10.7759/cureus.22097 medtronic received information in a literature article of a patient treated with onyx having complications.The artilce discusses a patient who underwent gamma knife srs post-onyx embolization of a spetzler-martin grade 4 left parasagittal avm in 2016.Four years after treatment, the patient presented with a high-grade glioma immediately adjacent to the targeted region.The case was of a 63-year-old female with a medical history significant for a grade 4 left parasagittal avm status post-onyx embolization and srs treatment (one session, prescription dose of 23 gy at the 50% isodose), with subsequent rupture and surgical resection three years later causing residual right-sided hemiplegia.Two years after resection, the patient presented to the emergency room due to declining mental and functional status over a three-week period.The patient underwent magnetic resonance imaging that demonstrated a cystic and enhancing posterior right frontal lesion measuring 37 × 33 × 28 mm.On examination, the pertinent positive neurological findings included right upper extremity stiffness without movement to command or painful stimulation, left upper extremity stiffness with weak voluntary movements (3/5), and bilateral lower extremity weakness (2/5).Clonus was present in the left ankle.The patient¿s cranial nerves were grossly intact, and light touch was intact bilaterally in the upper and lower extremities.The patient underwent a bicoronal incision for right frontal parasagittal craniotomy and tumor resection with no intraoperative comp lications.Tumor tissueanalysis was consistent with a giant cell glioblastoma, wild-type isocitrate dehydrogenase 1, p53 positive, with methylguanine methyltransferase gene promoter methylation.After the initial round of radiation therapy, the patient elected to pursue hospice therapy.

• 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: 17600397
• MDR Text Key: 321713369
• Report Number: 2029214-2023-01455
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

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: 08/22/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Female