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

Model Number 105-7000-060

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis as it was implanted; therefore the complaint could not be confirmed, and the event cause could not be reliably determined.However, it was reported that reflux was observed almost up to the detachment zone of the catheter tip.The onyx instructions for use advises: " do not allow more than 1 cm of the onyx¿ les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx¿ les reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment.".

Event Description

Medtronic received information that during an embolization procedure the onyx seemed to reflux almost up to the detachment zone of the catheter tip.As a result after the embolization was complete the physician could not remove the catheter.The physician was treating a cerebellum avm and for the embolization treatment the physician chose access through the superior cerebellum artery.After the injection of onyx 18, reflux was observed almost up to the detachment zone of the catheter tip.The physician paused during injection when the reflux was observed.The injection rate was 0.1ml/min.After successful completion of the embolization with onyx, he tried to detach the catheter but it would not detach.The physician attempted a couple of times but could not make it detach.In this maneuver the artery became straightened, which ultimately caused damage to the brain stem.The physician had to navigate an intermediate catheter to sca and was finally able to detach the catheter; however, 3cm of the detachable tip was left in the patient.The patient is in critical condition on a ventilator, and under critical observation of the neurologist in the hospital.

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 ; 9498733700
• MDR Report Key: 6028825
• MDR Text Key: 57399257
• Report Number: 2029214-2016-00904
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 09/16/2016

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: 10/23/2017
• Device Model Number: 105-7000-060
• Device Lot Number: A006450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: 09/16/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2014
• 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
• Patient Age: 58 YR
• Patient Weight: 62