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 Abscess (1690); Gastrointestinal Hemorrhage (4476)

Event Date 09/28/2020

Event Type  Injury  

Event Description

Kohlbrenner r, fidelman n, kohi mp, kumar v, kolli kp.Onyx embolization of an enlarging arterioportal pancreatic avm using a balloon-occlusion microcatheter.Diagnostic and interventional radiology (ankara, turkey).2021;27(3):458-459.Doi:10.5152/dir.2020.20416 medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to present the case of a patient with an arterioportal arteriovenous malformation (avm) of the pancreas that, after portal decompression, progressively enlarged over an 8-year period.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted:  - the patients avm was initial treated with a transjugular intrahepatic portosystemic shunt (tips).A multiphase ct of the abdomen in the setting of a gastrointestinal (gi) bleed performed 8 years after tips demonstrated arterial phase opacification of the portal vein through a large yakes type iv pancreatic avm involving the entire gland.When compared with the scan from 8 years prior using similar technique, the lesion had shown significant enlargement.The avm was then embolized using onyx.The patient required no subsequent blood transfusions and demonstrated no evidence of bowel ischemia or pancreatitis prior to discharge 3 days post-embolization.Endoscopy performed 6 months post-embolization in the setting of recurrent gi bleeding demonstrated a periampullary ulcer, small gastric varices, and small esophageal varices.As the etiology of the rebleeding could not be discerned, empiric embolization of additional feeding arteries was subsequently performed to further reduce arterioportal shunting, in conjunction with endoscopic sclerosis of several gastric varices.The patient was initiated on monthly octreotide injections 9 months after the initial embolization, and no further gi bleeding episodes were reported at 18-month follow-up.

Manufacturer Narrative

G2: citation: authors: kohlbrenner, r., fidelman, n., kohi, m.P., kumar, v., <(>&<)> kolli, k.P.Onyx embolization of an enlarging arterioportal pancreatic avm using a balloon-occlusion microcatheter.Diagnostic and interventional radiology 27(3):458-459 2021.Doi:10.5152/dir.2020.20416 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: 17715761
• MDR Text Key: 323040535
• Report Number: 2029214-2023-01636
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

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: 08/10/2023
• Initial Date FDA Received: 09/08/2023
• 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: 57 YR
• Patient Sex: Male