MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2024

Event Type  malfunction  

Event Description

Medtronic received a report that during embolization of second sitting of an arteriovenous malformation (avm) procedure, there was some residual avm left which was fed from right distal p2 posterior cerebral artery (pca).The physician took this apollo 1.5cm microcatheter and after filling it's dead space with dmso, started injecting the onyx-18 les.After injecting some of this onyx, he felt some resistance and the onyx was not coming out from apollo.The physician took out this apollo and took out a new apollo 3cm to finish of the procedure.The catheter was entrapped by onyx.There was no onyx reflux.There was no surgical or medicinal intervention required.There was no vasospasm.No portion of the catheter remains in the patient.There was catheter occlusion during onyx injection. the device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of avm.The avm was not in an eloquent region.It was noted the patient's vessel tortuosity was minimal.The access vessel was right distal p2 pca with a diameter of 1.2mm.Angiographic result post procedure was 90% avm was embolized.

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.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.

Manufacturer Narrative

Product analysis: ¿ as found condition: the apollo micro catheter and onyx 18 kit were returned for analysis within a shipping box.The onyx 18 kit was returned within an opened onyx 18 outer carton (b650374).The contents of the onyx 18 outer carton were removed.The onyx 18 (part: 50067-060-3 lot: b617014) and dmso (part: 50123-002 lot: b616191) vials were returned within their packaging tray.The apollo micro catheter was returned within an opened apollo outer carton (b484851) and an opened apollo inner pouch (b484851).¿ damage location details: the onyx 18 vial aluminum cap tab was found to have been removed, and the rubber stopper was punctured.The contents of the onyx 18 vial were partially consumed.The dmso vial aluminum cap tab was found to have been removed, and the rubber stopper was punctured.The contents of the dmso vial were partially consumed.Onyx was found within the apollo catheter hub.No bends or kinks were found with the apollo catheter body.The apollo catheter detachable tip was found intact.No damages were found with the apollo catheter distal tip.No onyx was observed within the apollo catheter distal tip lumen.The entire apollo catheter body was examined under magnification, no ruptures were found.¿ testing/analysis: a review of the lot history records of the onyx 18 kit reveals the onyx vial sub-assembly (part: 50067-060-3 lot: b617014) and dmso vial sub-assembly (part: 50123-002 lot: b616191) were used.It appears the correct onyx and dmso vials were returned.An in-house mandrel was inserted into the apollo catheter distal tip lumen.The mandrel became stuck after ~48.5cm.The remainder of the apollo catheter appears to be occluded with onyx.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter occlusion¿ report was confirmed.There is no evidence suggesting that the apollo micro catheter was defective.However, the onyx likely became exposed to water, saline, or blood, causing the onyx to solidify.This can occur in the hub, catheter lumen, or the needle used to draw the onyx from the vial.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ONYX AVM
• 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: 18699570
• MDR Text Key: 336514940
• Report Number: 2029214-2024-00273
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: B650374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2024
• Date Device Manufactured: 11/04/2023
• 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 Age: 21 YR
• Patient Sex: Male