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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problems Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Date 04/14/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Pulli, benjamin, christopher j.Stapleton, brian p.Walcott, matthew j.Koch, scott b.Raymond, thabele m.Leslie-mazwi, james d.Rabinov, and aman b.Patel.2020.'comparison of predictive grading systems for procedural risk in endovascular treatment of brain arteriovenous malformations: analysis of 104 consecutive patients'.Journal of neurosurgery 133 (2): 342¿50.Http://search.Ebscohost.Com/login.Aspx?direct=true<(>&<)>authtype=shib <(>&<)>db=edo<(>&<)>an=144979786<(>&<)>site=eds-live.Medtronic received a literature report pertaining to patients underwent adjunctive endovascular embolization of brain avms between 2002 and 2016 with the goal of reducing the surgical or hemorrhagic risk before definitive radiosurgical treatment.Ten major and 16 minor complications were encountered in 24 patients.A total of 104 patients were included, 45 female, average age of 43 years.Onyx was used in 68 of the total patients.Balloon-assisted onyx delivery with a scepter balloon catheter was utilized in 3 patients.There were also five instances of microcatheter break or retention with the marathon microcatheter and onyx.Toward the end of the study period, the physician s witched to the apollo detachable-tip microcatheter and have not encountered additional instances of microcatheter break, or retention since then.It was noted that there were onyx related complications, but the article did not specify which type of complications as they pertain to onyx.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10814535
• MDR Text Key: 217647375
• Report Number: 2029214-2020-01111
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

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?: Yes
• 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
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/09/2020
• 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: 43 YR