MAUDE Adverse Event Report: COVIDIEN (IRVINE) ONYX LES; AGENT, INJECTABLE, EMBOLIC

Device Problem Entrapment of Device (1212)

Patient Problem Perforation (2001)

Event Date 10/28/2010

Event Type  Injury  

Manufacturer Narrative

Citation: feng xu, wei ni, yujun liao, yuxiang gu, bin xu, bing leng, donglei song.Onyx embolization for the treatment of brain a rteriovenous malformations.Acta neurochir (2011).Published online: 28 october 2010 the purpose of this article was to study the experience in the treatment of brain avms with onyx embolization.Between january 2004 and december 2007, 86 patients with brain avms were embolized with onyx.The authors conclude that although onyx allows moderate obliteration rates, combined management, such as adjunctive embolization with microsurgery or radiosurgery, may be effective for selected large avms.The mean patient age was 30.3 years (range, 8¿55 years).There were 51 men and 35 women.The products were not returned for evaluation as this was an event captured through literature review.There is limited patient and device information available; in this article it was reported that both the marathon and ultraflow microcatheters were used.However, it was not reported which microcatheter was used in this procedure.Additionally, the amount of onyx reflux/entrapment was not captured in the article.Based on the reported information, review of ifus, and review of literature to investigate the complaint, the most likely cause for the reported event is procedure related.Additional information has been requested on each case; should the information become available, a supplemental report will be submitted.Mdrs from this event: 2029214-2017-00499, 2029214-2017-00500 mdrs from this literature review: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00501.

Event Description

Medtronic received information through literature review that in 1 patient, arterial perforation occurred with catheter (marathon or ultraflow) manipulation was sealed(entrapped) with glue/onyx.The patient tolerated the perforation without neurologic deficit.The purpose of this article was to study the experience in the treatment of brain avms with onyx embolization.Between january 2004 and december 2007, 86 patients with brain avms were embolized with onyx.Clinical presentation included intracerebral hemorrhage in 32 patients, seizures in 25 patients, headaches in 20 patients, neurologic deficits in 3 patients, and in 6 patients the avm was an incidental finding.Embolization-related permanent morbidity was 3.5%, whereas mortality was 1.2%.The authors conclude that although onyx allows moderate obliteration rates, combined management, such as adjunctive embolization with microsurgery or radiosurgery, may be effective for selected large avms.The mean patient age was 30.3 years (range, 8¿55 years).There were 51 men and 35 women.According to the spetzler¿martin grading scale [35], 3 avms (3.5%, 3/86) were grade i, 13 (15.1%, 13/86) were grade ii, 45 (52.3%, 45/86) were grade iii, 19 (22.1%, 19/86) were grade iv, and 6 (7.0%, 6/86) were grade v (table 3).A total of 74 (86%) of the avms were located in eloquent regions.Staged sessions of embolization were planned for partially occluded avms.Citation: feng xu, wei ni, yujun liao, yuxiang gu, bin xu, bing leng, donglei song.Onyx embolization for the treatment of brain a rteriovenous malformations.Received: 9 august 2010 / accepted: 14 october 2010 / published online: 28 october 2010 acta neurochir (2011) pes from this literature review: (b)(4).

Manufacturer Narrative

Corrected information: mdrs from this event: 2029214-2017-00499, 2029214-2017-00500 mdrs from this literature review: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00501, 2029214-2017-00502, and 2029214-2017-00503.

Manufacturer Narrative

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

• Brand Name: ONYX LES
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6517081
• MDR Text Key: 73557206
• Report Number: 2029214-2017-00500
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: Not provided; 03/28/2017
• Supplement Dates FDA Received: 04/24/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 30 YR