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

Model Number 105-7000-060

Device Problem Entrapment of Device (1212)

Patient Problem Embolism (1829)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis as it was left in the patient; therefore the complaint could not be confirmed, and the event cause could not be reliably determined.Based on the reported information, the physician did not control the onyx reflux resulting in onyx retrograde flow over the proximal marker band of the detachable tip on the apollo microcatheter.Per onyx les instruction for use: "do not allow more than 1cm of onyx les reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux or prolonged injection time may result in difficult catheter removal and catheter entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long term effects of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection, or catheter migration.".

Event Description

Medtronic received information that the apollo catheter became stuck inside the patient's brain during an avm embolization procedure.The device was cut at the patient groin and the piece was retained in the patient.During embolization of the avm the apollo became stuck inside of the patient's brain.The injection rate of the onyx did not exceed 690kpa/100psi.As the onyx was injected, the physician paused to screen, but the pause was less than 2 minutes between injections.There was reflux of the onyx on the apollo.The onyx cast went beyond the proximal marker-beyond the separation point/detachment zone of the catheter.As a result, the apollo was entrapped and the physician applied force during removal with significant movement of the pons.The device was cut at the patient groin and everything except the hub, where the physician cut the catheter was left in the patient and the avm was not fully treated.The current condition of the patient is well.

Manufacturer Narrative

Additional information: please reference mdrs 2029214-2016-00969 and 2029214-2016-00972 for the other mdrs for this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6074568
• MDR Text Key: 59008824
• Report Number: 2029214-2016-00973
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2016

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 Expiration Date: 11/10/2018
• Device Model Number: 105-7000-060
• Device Lot Number: A227702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; 10/06/2016
• Supplement Dates FDA Received: 11/02/2016; 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2016
• 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): Required Intervention
• Patient Age: 38 YR