FDA Adverse Event Death Summary report: N

VENA TECH-LGM

MDR report key: 124222 · Received October 1, 1997

Report

Report Number
124222
Event Type
Death
Date Received
October 1, 1997
Date of Event
September 26, 1997
Report Date
September 30, 1997
Manufacturer
VENA TECH B. BRAUN MEDICAL
Product Code
DTK
Report Source
User Facility report
Reporter Location
OH, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A VENA CAVA FILTER WAS IMPLANTED IN THE PT. IT FAILED TO DEPLOY AND MIGRATED TO THE HEART. IT BECAME LODGED IN THE PULMONARY ARTERY. THE PT SUBSEQUENTLY DIED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VENA TECH-LGM Implant VENA CAVA FILTER DTK VENA TECH B. BRAUN MEDICAL 31327 *

Patients

Seq Age Sex Outcome Treatment
1 38 YR Death