AZUR PERIPHERAL HYDROCOIL

Report

Report Number: 2032493-2010-00014
Event Type: Death
Date Received: May 14, 2010
Date of Event: April 16, 2010
Report Date: April 16, 2010
Manufacturer: MICROVENTION, INC.
Product Code: KRD
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INVOLVED COIL WAS NOT RETURNED FOR EVAL. THERE IS NO INDICATION OR CLAIM OF A DEVICE DEFECT OR MALFUNCTION. THE DEVICE HISTORY RECORD FOR THIS AZUR EMBOLIZATION COIL REVEALS NO ANOMALIES OR NON-CONFORMANCES THAT ARE KNOWN TO HAVE INCREASED THE LIKELIHOOD OF, OR CAUSED, OR CONTRIBUTED TO, THIS EVENT.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT A PT WHO HAD PRESENTED WITH A LIFE-THREATENING BRONCHIAL ARTERY HEMORRHAGE DIED DURING AN ATTEMPT AT HEMORRHAGE CONTROL USING AN AZUR EMBOLIZATION COIL. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO MAKE AN ATTEMPT TO DEPLOY THE AZUR COIL INTO THE BRONCHIAL ARTERY EVEN THOUGH THE PT'S CONDITION WAS VERY UNSTABLE AND THE PROGNOSIS FOR SURVIVAL WAS POOR. THE ATTEMPTED DEPLOYMENT UNDER THE EMERGENT CIRCUMSTANCES REPORTEDLY, CREATED SIGNIFICANT DIFFICULTIES IN POSITIONING OF THE MICROCATHETER (NOT OF THE COMPANY'S MANUFACTURE) THAT WAS USED TO DELIVER THE COIL. THE POOR POSITION OF THE MICROCATHETER RESULTED IN SUBOPTIMAL POSITIONING OF THE AZUR COIL WHERE ONLY PART OF THE COIL WAS DEPLOYED IN THE BRONCHIAL ARTERY AND THE REMAINING PORTION EXTENDED INTO THE PT'S AORTA. THE CLINICAL STAFF DID NOT BELIEVE THE AZUR EMBOLIZATION COIL CAUSED OR CONTRIBUTED TO THE DEATH OF THIS PT. HOWEVER, THE DEVICE WAS IN USE DURING THE REPORTED EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED VOLUNTARILY AS A PRECAUTIONARY MEASURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AZUR PERIPHERAL HYDROCOIL	EMBOLIZATION COIL	KRD	MICROVENTION, INC.	45-480310	99102106

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death