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 Bacterial Infection (1735)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.See attached literature article.No specific device information provided.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

Patterson, t.T., webb, m., wallace,d.J., carson, j.L., mascitelli, j.R.Suboccipital, supracerebellar, infratentorial approach for microsurgical clipping of a ruptured tentorial, straight sinus type dural arteriovenous fistula.World neurosurg.2020.142:131-135.Doi: 10.1016/j.Wneu.2020.06.101 summary: dural arteriovenous fistulas (davfs) can often be successfully treated with endovascular embolization; however, surgery is occasionally still required.- case description: herein, we discuss a 65-year-old male patient who presented with a hunt-hess iv subarachnoid hemorrhage, intraventricular hemorrhage, and cerebellar intracranial hemorrhage secondary to a ruptured borden type iii tentorial (straight sinus) davf.Angiography revealed supply from the left occipital and posterior meningeal arteries and direct drainage into the cerebellar cortical veins with venous aneurysms in both cerebellar hemispheres.Both transarterial and transvenous embolization were attempted, without success.Therefore, the patient was taken to the operating room for clip ligation of the davf.The operative video demonstrates a bilateral suboccipital craniotomy and supracerebellar infratentorial approach for surgical clipping of the davf.- conclusions: the case and operative video provide a valuable addition to surgical literature in an era where surgical management of davfs has become relatively rare.Reported events: a single occipital artery feeder was embolized with onyx but did not penetrate the nidus.Then a transvenous approach was attempted, but the venous aneurysm and fistulous point could not be reached via this route either.Given the inability to cure the lesion by endovascular means, the decision was made to proceed with surgical clip ligation.The occipital artery was preoperatively occluded with onyx to reduce surgical bleeding during the opening.Postoperatively, the patient required a tracheostomy, gastric feeding tube, and ventriculoperitoneal shunt.He developed methicillin-resistant staphalococcus aureus pneumonia while in the intensive care unit and subsequent methicillin-resistant s.Aureus wound infection.The posterior fossa craniotomy wound was revised without complication and healed well thereafter.The patient was ultimately discharged to a rehabilitation facility.

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.

Event Description

Additional information received reported that this case report described a surgical clipping of a dural fistula.The patient also had a pre-op embo with onyx.There were no complications related to any medtronic products used.

• 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: 17773082
• MDR Text Key: 323720470
• Report Number: 2029214-2023-01761
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/06/2023
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Male