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

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

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

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

The embolic material will not be returned for analysis as it was consumed in the intervention.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked with mdr: 2029214-2019-00190.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the treatment of a distal dural fistula, the marathon catheter encountered resistances when attempted to be retrieved, after the liquid embolization was completed.The catheter was reported to have stretched and separated at the distal segment.The distal segment was unable to be removed and was left within the ophthalmic and internal carotid artery.However, the vessels remained patent.The patient was asymptomatic post the embolization procedure.During the procedure, there was 45 seconds pause between onyx injections and 2cm of onyx reflux was noted at the distal tip of the catheter.The devices were reported to have been prepared and used per the instructions for use (ifu).The vessel was normal tortuosity.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8412565
• MDR Text Key: 138537066
• Report Number: 2029214-2019-00191
• Device Sequence Number: 1
• Product Code: MFE
• UDI-Device Identifier: 00847536006171
• UDI-Public: 00847536006171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019

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: 06/27/2021
• Device Model Number: 105-7100-060
• Device Lot Number: A702530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2018
• 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: 68 YR