FDA Adverse Event Malfunction Summary report: N

ONYX

MDR report key: 6655148 · Received June 20, 2017

Report

Report Number: 2029214-2017-00804
Event Type: Malfunction
Date Received: June 20, 2017
Date of Event: March 10, 2012
Report Date: May 24, 2017
Manufacturer: COVIDIEN (IRVINE)
Product Code: MFE
PMA / PMN Number: P030004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

STEMER AB, BANK WO, ARMONDA RA, ET AL. J NEUROINTERVENT SURG (2012). DOI:10.1136/NEURINTSURG-2011-010214 THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. THE ONYX MODEL AND LOT NUMBERS WERE NOT PROVIDED. THE ARTICLE PROVIDED LIMITED INFORMATION ON THIS EVENT. A CAUSE FOR THE REPORTED ONYX ENTRAPMENT OF A CATHETER NOT BE CONCLUSIVELY DETERMINED. MDRS RELATED TO THIS ARTICLE: 2029214-2017-00803 2029214-2017-00804.

Description of Event or Problem · 1

MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF A RETAINED MICROCATHETER AFTER ONYX EMBOLIZATION. THE PURPOSE OF THIS STUDY WAS TO DEMONSTRATE THAT ACUTE ENDOVASCULAR EMBOLIZATION OF RUPTURED BAVMS IS SAFE AND FEASIBLE. THE AUTHORS REVIEWED 21 PATIENTS WHO UNDERWENT ONYX EMBOLIZATION OF RUPTURED BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). OF THE PATIENTS, 9 WERE MEN AND 12 WERE WOMEN; MEAN AGE WAS 38 YEARS. THE ARTICLE STATES THAT THE FOLLOWING ASYMPTOMATIC TECHNICAL COMPLICATIONS OCCURRED DURING STAGE I ONYX EMBOLIZATION: - A RETAINED MICROCATHETER (UNKNOWN MANUFACTURER) IN THE LEFT VERTEBRAL

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
434933	ONYX	AGENT, INJECTABLE, EMBOLIC	MFE	COVIDIEN (IRVINE)

Patients

Seq	Age	Sex	Outcome	Treatment
1