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

Device Problem Entrapment of Device (1212)

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Perforation (2001); Foreign Body In Patient (2687)

Event Date 12/26/2008

Event Type  Injury  

Manufacturer Narrative

Hauck, e., welch, b., white, j., purdy, p., pride, l., and samson, d.(2009).Preoperative embolization of cerebral arteriovenous malformations with onyx.American journal of neuroradiology, 30(3), 492-495.Doi:10.3174/ajnr.A1376.The onyx will not be returned for evaluation as it remains in the patients.The onyx model and lot numbers were not provided.The article provided limited information on these events.A cause for the reported events could not be conclusively determined.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.

Event Description

Medtronic literature review found reports of patient complications during or after onyx embolization.The purpose of this article was to investigate the risks of preoperative cerebral arteriovenous malformations (cavms) with onyx.The authors identified 41 patients who underwent preoperative cavm onyx embolization in 82 procedures; median age was 41 years, 15 were male and 26 were female.Onyx was either used as the sole embolic agent or in conjunction with other materials.In these patients, the intent was to reduce flow in the cavm in order to reduce the risk and increase success of subsequent treatment (usually surgery).The article states that permanent neurological deficit (>6months) occurred in five patients: one patient experienced a small biophthalamic infarct with mild cognitive deficit and difficulties with calculations after the initial embolization of a pineal region cavm - two patients with cerebellar avms experienced mild ataxia and dysmetria after initial embolization.Ct scan revealed a new cerebellar hypoattenuation.One patient experienced new persistent hemiparesis after a fourth embolization of a large frontal cavm.During embolization, the patient experienced a perforation with a small intraparenchymal hemorrhage in the posterior frontal lobe.One patient ((b)(6), female) underwent partial onyx embolization of a large, left-sided frontotempoparietal cavm with the intent to treat an intranidal feeding aneurysm.The feeding aneurysm was completely occluded; the patient experienced new aphasia and hemiparesis.Asymptomatic technical complications occurred in 16 patients: nine patients experienced asymptomatic small vessel perforation (contrast extravasation or hemorrhage on post-procedure ct) - three patients experienced new lacunar infarct without neurological deficit (documented on post-procedure mri or ct) - microcatheter (unknown manufacturer) was retained in four procedures, which was then removed during surgery without neurological consequences.

• Brand Name: ONYX
• 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: 6652811
• MDR Text Key: 77915418
• Report Number: 2029214-2017-00798
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• 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; Required Intervention