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

Device Problems Entrapment of Device (1212); Poor Quality Image (1408); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2012

Event Type  malfunction  

Event Description

Citation: ramsey ashour, et al.Safety and efficacy of onyx embolization for pediatric cranial and spinal vascular lesions and tumors.Neurosurgery.2012 oct;71(4):773-84.Published online june 15, 2012.The following report was received by medtronic (covidien) through review of literature: there were two retained microcatheters (brand name unknown), both without clinical consequence.Skull x-ray showing retained, broken microcatheter along with extravasated onyx (arrow) in the distal left cervical vertebral artery proximal to the posterior inferior cerebellar artery secondary to catheter rupture during arteriovenous malformation embolization.The left vertebral artery was sacrificed with coils to prevent distal emboli from the retained catheter and the extravasated onyx.The patient remained asymptomatic with good flow from the contralateral codominant vertebral artery.This phenomenon was observed in 2 high-flow lesions: one arteriovenous malformation (avm) and one vein of galen malformation (vogm) without clinical consequence (figure 4).In both cases, because of the extremely high flow within the catheterized vessel, the injected onyx exited the microcatheter tip in the shape of a very thin "string" rather than a "ball."this made visualization of the onyx difficult despite roadmap imaging, allowing unrecognized transit through the venous system and into the pulmonary artery.In both cases, onyx accumulation in the pulmonary artery was in the shape of a "ball of yarn.".

Manufacturer Narrative

Http://www.Ncbi.Nlm.Nih.Gov/pubmed/22989958.This report was created to capture the malfunctions related to the onyx.The onyx will not be returned for evaluation as they were consumed in the events; therefore the complaint could not be confirmed, and the event causes could not be determined.Based on the reported information, there is no evidence suggesting that the devices were defective, but rather procedure related events.In addition, the lot history record review was not possible since the lot number was not reported.Information received from the same article as mfr: 2029214-2015-00456.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ONYX AVM
• 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 ; 9496801224
• MDR Report Key: 4740095
• MDR Text Key: 17205038
• Report Number: 2029214-2015-00455
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 10 YR