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

Model Number 105-7315-080

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was consumed in the event.Based on the reported information, there did not appear to have been any defect of the device during use but rather a procedure related event.Related mdrs for this event: 2029214-2018-01045.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the rebar microcatheter tip became stuck inside the aneurysm sac after endoleak was treated with coil/onyx causing resistance to be felt along with stretching of the microcatheter tip as it was being removed from the aneurysm which subsequently broke off and that tip fragment remained in the aneurysm sac.There was possible report of injury to marginal artery connecting ima/sma from the foreign body being left in the patient.There was a potential lack of blood flow that caused damage to the bowel.The patient was put under observation.The patient¿s vasculature was moderate in tortuosity.

• Brand Name: ONYX PV
• 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 ; 9498373700
• MDR Report Key: 8150328
• MDR Text Key: 129891517
• Report Number: 2029214-2018-01046
• 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: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: 105-7315-080
• Device Lot Number: A635159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2018
• 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): Disability