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

Device Problem Entrapment of Device (1212)

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

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Article website: http://ine.Sagepub.Com/content/21/5/620.Long there is limited information about the device and/or the patient, therefore all product problem events were captured in this report.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 implanted in the patient; therefore, the event cause could not be determined.The marathon microcatheter device is reported in mdr mfr# 2029214-2015-05105.

Event Description

Medtronic received information from literature that three catheter entrapment cases occurred during onyx procedures.The authors experienced three patients with difficulties of catheter entrapment with brain arteriovenous malformations (bavms) embolization.Two of the patients had removal of the microcatheter by ¿¿pull-push-pull¿¿ technique with one still having a retained catheter when utilized the recommended ev3 protocol.For the patient with the catheter still retained through the femoral artery, that patient was put on anticoagulant regimen with further follow-up on the surgical resection of the bavm.One and six months follow-up showed no further neurological complications in all three patients.In this literature article, the authors report ¿¿pull-push-pull¿¿ technique for retrieval of an entrapped microcatheter during onyx embolization of bavms.The authors analyzed a total of 37 patients that underwent bavm embolization with either onyx 18 or 34 at their institution.Standard embolization techniques were utilized with the use of marathon microcatheter.When difficulty in retrieving the microcatheter arose, the authors used the ¿¿pull-push-pull¿¿ technique.Citation: vu pd, grigorian aa.Microcatheter entrapment retrieval from onyx embolization in brain arteriovenous malformations: a technical note.Interv neuroradiol.2015 oct;21(5):620-3.Doi: 10.1177/1591019915583226.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRIVINE); 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: 5201690
• MDR Text Key: 30412291
• Report Number: 2029214-2015-05104
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PMA P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/04/2015
• 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