VANA CAVA FILTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for VANA CAVA FILTER manufactured by Medi-tech.

Event Text Entries

[14000] A vena cava filter failed to open when placed in the patient. Due to the risks to remove it, it was left in place. There was no known adverse outcome to the patient. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	20899
MDR Report Key	20899
Date Received	1994-07-29
Date of Report	1994-07-13
Report Date	1994-07-13
Date Added to Maude	1995-03-21
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	0
Initial Report to FDA	0
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	VANA CAVA FILTER
Product Code	LWT
Date Received	1994-07-29
Device Availability	*
Implant Flag	*
Device Sequence No	1
Device Event Key	20798
Manufacturer	MEDI-TECH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1994-07-29