MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7000-060

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problems Visual Impairment (2138); Cognitive Changes (2551)

Event Type  Injury  

Manufacturer Narrative

The device will not been returned for analysis as it was implanted; therefore the complaint could not be determined.In this event, it was reported that the reflux of onyx surrounding the detachable microcatheter tip.Per onyx instruction for use: "onyx¿ les reflux along the distal tip of the micro catheter:.The amount of reflux that can be accepted must always be compared to the angio-architecture of the malformation to minimize risk of unintended embolization or difficult catheter removal.In general, minimize the reflux to less than 1 cm along the distal tip of the micro catheter." same event as reported in mdr 2029214-2015-05198.

Event Description

Medtronic received information that an apollo microcatheter tip was retained close to arteriovenous malformation site during an onyx embolization procedure.The patient suffered left homonymous hemianopsia and moderate widespread cognitive impairment following the onyx embolization.It was reported that the patient underwent embolization procedure of a spetzler-martin grade iii left occipital arteriovenous malformation with associated intraventricular hemorrhage with supply via the distal left posterior cerebral artery (pca) with deep venous drainage to the vein of galen.Entry was made into the distal left vertebral artery with a detachable tip apollo microcatheter navigated into the distal left posterior cerebral artery at the site of the recently ruptured avm.Onyx 18, a total of 1.5ml, was used to completely occlude the avm feeding arteries, nidus and proximal draining veins.Localized reflux of onyx surrounding the detachable tip microcatheter, which could not be detached distally, was however detached more proximally with a segment of retained microcatheter in the left posterior cerebral artery and basilar apex.Four days post procedure, the mri result showed a small area of restricted diffusion consistent with ischemic change in the distribution of the left posterior cerebral artery around the embolized avm and extending into the left side of the splenium of the corpus callosum.There was discontinuous flow in the left pca.Approximately three months post procedure, a follow-up mr angiography demonstrated complete occlusion of the majority of the avm nidus.The retained microcatheter tip is noted within the left posterior cerebral artery extending to the basilar apex without underlying arterial stenosis, occlusion or territorial infarction.

Manufacturer Narrative

Additional information same event as reported in mdr 2029214-2015-05198 and 2029214-2016-00009.

Manufacturer Narrative

Additional information image analysis by an independent medical advisor concluded that the embolization of the high-grade avm was successful.The avm was located deep in the occipital lobe and the access was difficult.The catheter was placed in a tortuous artery with a 180 degree loop.Onyx refluxed proximal to detachable zone; however the reflux was necessary to embolize the avm nidus.The onyx was injected over a long period of time, at least one hour.At the conclusion of the procedure, the physician was able to completely occlude the avm.The catheter tip was detached proximal to the detachment zone; however, it was expected considering the difficult location, reflux, and long procedure time.The independent medical advisor stated that the patient's deficit is unlikely to be caused by the catheter tip left in the vessel because the pca was patent to the avm nidus.The ischemic change in the distribution of the left posterior cerebral artery around the embolized avm was caused by the embolized avm.The patient's symptoms of left homonymous hemianopsia and moderate widespread cognitive impairment were related to the embolization of the avm and were not caused by the catheter tip left in the pca.Based on this image analysis, the onyx and apollo micro catheter were deemed to perform as intended with no device issue.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5290364
• MDR Text Key: 33310220
• Report Number: 2029214-2015-05197
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2015

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
• Device Model Number: 105-7000-060
• Device Lot Number: 9829926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2016; 03/07/2016
• 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): Disability