MAUDE Adverse Event Report: MEDTRONIC COVIDIEN ONYX; AGENT, INJECTABLE, EMBOLIC

Device Problem Entrapment of Device (1212)

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

Event Date 08/12/2014

Event Type  Injury  

Manufacturer Narrative

Citation: spiotta am, james rf, lowe sr, et al."balloon-augmented onyx embolization of cerebral arteriovenous malformations using a dual-lumen balloon: a multicenter experience.J neurointervent surg 2015;7:721¿727.The device will not be returned for evaluation as it was implanted in the patient; therefore we are unable definitively determine the cause of this event.As per the onyx ifu: 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.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 are unknown, but potentially could include clot formation, infection, or catheter migration.Information received from the same report as mfr:2029214-2016-00663.

Event Description

Medtronic received information through review of literature that one patient the scepter catheter was retained within the onyx cast, fracturing during the attempt to remove it.This was directly related to reflux of embolisate beyond the proximal marker of the balloon catheter.A stent was subsequently placed along the length of the fractured fragment, anchoring it against the arterial wall.In another instance there was an episode of reflux which we did not attribute to failure of the balloon catheter device; this complication was related to onyx reflux proximal to the balloon in the arterial pedicle of interest, but the reflux occurred in a retrograde fashion through the nidus of the avm (distal to the position of the balloon catheter) via a nidal vessel connected to the proximal segment of the arterial pedicle and not around the balloon itself in the traditional sense.The balloon catheter was removed in this instance with some difficulty.There was no serious injury as a result of this event.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; ca; irvine 92618 ; 9498373700
• MDR Report Key: 5852509
• MDR Text Key: 51340288
• Report Number: 2029214-2016-00664
• Device Sequence Number: 1
• Product Code: MFE
• 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: 07/08/2016

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: 07/08/2016
• Initial Date FDA Received: 08/06/2016
• 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