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

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/01/2010

Event Type  Injury  

Event Description

Simon et al.Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms.Neurosurgery 66 [ons suppl 1]:ons92-ons98, 2010.Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: a patient with a smaller ventral variant aneurysm had successful occlusion with onyx, which was delivered with multiple cycles of balloon inflation, injection and reperfusion.After the microcatheter was removed, immediate angiography demonstrated that the onyx was migrating out of the aneurysm lumen.The balloon was re-inflated, pushing the cast back into the aneurysm.The balloon was left inflated for an additional 10 minutes in an attempt to secure the cast back into the aneurysm but this was unsuccessful.A vascular reconstruction device (vrd) was navigated across the inflated balloon overlying the aneurysm neck without difficulty.Onyx cast was secure.Information received from the same article as mfr report #s 2029214-2015-00330 2029214-2015-00331 2029214-2015-00331.

Manufacturer Narrative

Http://journals.Lww.Com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable.59.Aspx.This report was created to capture complications reported for patient number four.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were consumed in the event; therefore the cause could not be determined.(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, CA 92618 ; 9496801224
• MDR Report Key: 4659280
• MDR Text Key: 17214958
• Report Number: 2029214-2015-00325
• Device Sequence Number: 1
• Product Code: OBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H060003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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): Required Intervention
• Patient Age: 64 YR