MAUDE Adverse Event Report: IRVINE ONYX ANEURYSM; POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Facial Nerve Paralysis (1846); Neurological Deficit/Dysfunction (1982); Optical Nerve Damage (1986)

Event Date 07/08/2008

Event Type  Injury  

Event Description

Citation: ronie peske et al.Evaluation of onyx hd-500 embolic system in the treatment of 84 wide neck intracranial aneurysms.Neurosurgery vol.64 number 5.May 2009.Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: sixty- nine patients with 84 aneurysms were treated.Most of the aneurysms were located in the anterior circulation (80 of 84 aneurysms), were unruptured (74 of 84 aneurysms), and were incidental.Ten presented with subarachnoid hemorrhage, and 15 were symptomatic.All aneurysms had wide necks (neck _4 mm and/or dome- to- neck ratio_1.5).Fifty aneurysms were small (_12 mm), 30 were large (12 to _25 mm) and 4 were giant.Angiographic follow- up was available for 65 of the 84 aneurysms at 6 months, for 31 of the 84 aneurysms at 18 months, and for 5 of the 84 aneurysms at 36 months.Onyx leakage (onyx extravasation) occurred in 18 patients.It was mild in 10, moderate in six and severe in two.Internal carotid artery stenosis and thrombosis was seen in one patient (5 months after treatment).Severe internal carotid artery stenosis (50% of the lumen) occurred in four patients.Onyx extravasation was in two of these patients, and moderate extravasation occurred in one patient, there was no extravasation in one patient.At the clinical follow-up at 6 months, the mass effect was cured in four patients.There was partial improvement in two patients (optic nerve) and no change in three patients.(two with six nerve lesions and one with third nerve palsy).In two of these patients, the symptoms initially worsened (third and sixth cranial nerves), with regression to the previous state in 15 days in one patient and in 3 months in the other.Two patients developed a new cranial nerve deficit after treatment; 1 patient presented with new compression of the optic nerve with permanent visual deficiency, and the presented with temporary sixth nerve palsy.Of the aneurysms with optic nerve compression, only minor improvement was seen after embolization in both cases.Information received from the same article as mfr #s 2029214-2015-00317, 2029214-2015-00337.

Manufacturer Narrative

Http://www.Ncbi.Nlm.Nih.Gov/pubmed/19404128.The lot history record review was not possible since the lot number was not reported.The onyx were not returned for analysis; therefore the event causes could not be determined.The events occurred in the patients during procedure and post procedure and their causes were unknown.(b)(4).

• Brand Name: ONYX ANEURYSM
• Type of Device: POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL
• Manufacturer (Section D): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9496801224
• MDR Report Key: 4659390
• MDR Text Key: 5600706
• Report Number: 2029214-2015-00326
• Device Sequence Number: 1
• Product Code: OBA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: H060003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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
• Date Manufacturer Received: 03/05/2015
• 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 Outcome(s): Other; Disability