FDA Adverse Event Death Summary report: N

CORDIS

MDR report key: 1844075 · Received September 22, 2010

Report

Report Number
1844075
Event Type
Death
Date Received
September 22, 2010
Date of Event
September 10, 2010
Report Date
September 17, 2010
Manufacturer
CORDIS CORP
Product Code
DTK
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
KS, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PRE-OP X-RAY ON (B)(6) 2010, SHOWED VENA CAVA FILTER HAD MIGRATED INTO THE RIGHT ATRIUM. THE PROCEDURE TO REMOVE THE FILTER WAS SUCCESSFUL, HOWEVER, THE PT COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH IMMEDIATELY UPON REMOVAL. A STAT ECHOCARDIOGRAM SHOWED RIGHT ATRIAL COLLAPSE AND PT STATUS DECLINED RAPIDLY LEADING TO A CODE BLUE, IMMEDIATE TRANSFER TO OPERATING ROOM FOR ATRIAL REPAIR. PT DIED TWO DAYS FOLLOWING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CORDIS TRAPEASE IVC FILTER DTK CORDIS CORP UNK

Patients

Seq Age Sex Outcome Treatment
1 60 YR Death