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

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problems Rupture (2208); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Information received from the article: spiotta et al.Use of the sceptre c dual-lumen balloon microcatheter in onyx embolization of cerebral arteriovenous malformations: a multi-center experience.J neurointervent surg 2014; 6(suppl 1): a1-a78.Seventeen patients had avms (arteriovenous malformation) that were treated with onyx, 0.014 inch guidewire and sceptor c balloon.The age was between 22 to 64 yrs.In all the cases, the balloon catheter was advanced to the arterial pedicle to be treated and onyx injection began after the balloon was inflated.A total of 34 arterial pedicles were embolized.The result showed that balloon assisted onyx embolization using a dual lumen catheter is a safe and effective way for treatment of avms.There were two catheter related complications.One of these complications was an intraprocedural rupture of a feeding pedicle and one was a retained catheter fragment within an onyx cast.S.The mean number of pedicles embolised per patient was 2 (range 1 to 5) and avms were treated in a wide variety of intracranial locations (size 3.55 ã¿â± 1.61 cm).In all cases the sceptre c catheter was navigated into the desired position.Fluoroscopy time for the entire procedure was 48 ã¿â± 26 min (mean fluoroscopy time per arterial pedicle embolised was 28 min).Immediate angiographic outcomes: complete occlusion (n = 2), 90ã¢â¿¬â¿¿99% reduction in nidus (n = 5), 70ã¢â¿¬â¿¿89% reduction (n = 6), 50ã¢â¿¬â¿¿70% (n = 4), 25ã¢â¿¬â¿¿49% reduction (n = 3) and {25% reduction (n = 1).Two catheter related complications (11%) were observed; an intraprocedural rupture of a feeding pedicle and a retained catheter fragment within the onyx cast.Conclusion in our experience, balloon-augmented onyx embolization utilising a dual lumen catheter is safe and effective in the treatment of avms, allowing more efficient and controlled injection of onyx with a decreased risk of reflux and drastically decreased fluoroscopy times.

Manufacturer Narrative

This report was created to capture the two periprocedural complications all received from the article: spiotta et al.Use of the sceptre c dual-lumen balloon microcatheter in onyx embolization of cerebral arteriovenous malformations: a multi-center experience.J neurointervent surg 2014; 6(suppl 1): a1-a78.(b)(4).

• Brand Name: ONYX
• 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: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4509382
• MDR Text Key: 5443643
• Report Number: 2029214-2015-00115
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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