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

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/28/2010

Event Type  malfunction  

Manufacturer Narrative

Citation: feng xu, wei ni, yujun liao, yuxiang gu, bin xu, bing leng, donglei song.Onyx embolization for the treatment of brain arteriovenous 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; within the article, there was no confirmed defect or device deficiency.The amount of catheter entrapment or reflux was not reported 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, the event will be readdressed accordingly.Mdrs from this event: 2029214-2017-00496, 2029214-2017-00497 mdrs from this literature review: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00498, 2029214-2017-00499, 2029214-2017-00500, 2029214-2017-00501.

Event Description

Medtronic received information through literature review that periprocedurally, the microcatheter (marathon or ultraflow) was inadvertently glued to the vessel in 3 cases and was left in place without clinical sequelae.The patients were being treated with onyx embolization for brain avms.In the patients were the catheters were retained, low-molecular weight heparin was subcutaneously injected at 12 hours for 48 hours, followed by oral aspirin for 3 months at a dose of 100mg/day.

Manufacturer Narrative

Corrected information: mdrs from this event: 2029214-2017-00496, 2029214-2017-00497 mdrs from this literature review: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495,2029214-2017-00498, 2029214-2017-00499, 2029214-2017-00500, 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: 6517052
• MDR Text Key: 73624469
• Report Number: 2029214-2017-00497
• 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?: No
• Is this a Product Problem Report?: Yes
• 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 Age: 30 YR