FDA Adverse Event Death Summary report: N

VENA TECH LGM VENA CAVA FILTER

MDR report key: 341773 · Received July 13, 2001

Report

Report Number
341773
Event Type
Death
Date Received
July 13, 2001
Date of Event
July 13, 2001
Report Date
July 13, 2001
Manufacturer
B. BRAUM MEDICAL INC
Product Code
DTK
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

PT UNDERWENT PROCEDURE TO HAVE VENA CAVA FILTER PLACED FOR THROMBUS. BRAUN VENA TECH VENA CAVA FILTER PLACED IN THE INFRARENAL INFERIOR VENA CAVA. SUCCESSFUL DEPLOYMENT CONFIRMED BY CT OF ABDOMEN AND PELVIS THE SAME DAY. THREE DAYS LATER IN THE EVENING , PT BEGAN TO BE SHORT OF BREATH, PORTABLE CHEST X-RAY SHOWED IVC FILTER TO HAVE MIGRATED INTO THE HEART. PT EXPIRED AT 00:01 THE NEXT DAY AUTOPSY BEING DONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
32088 VENA TECH LGM VENA CAVA FILTER * DTK B. BRAUM MEDICAL INC * F0146700

Patients

Seq Age Sex Outcome Treatment
1 56 YR Death