EN SNARE®
Received Sep 3, 2025 · Event occurred Dec 3, 2019
Report 1721504-2025-00329 · MDR key 22952885
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pulmonary Edema
- Perforation of Vessels
- Pulmonary Edema
- Perforation of Vessels
Narrative
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO LOT NUMBER WAS PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND A SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED.
Description of Event or Problem
LITERATURE ARTICLE REPORTED DURING SINGLE-SESSION IVC FILTER RETRIEVAL AND ILIOCAVAL RECANALIZATION, EN SNARE WAS USED AS THE PRIMARY RETRIEVAL METHOD. ADVANCED TECHNIQUES WERE REQUIRED IN MANY CASES DUE TO FILTER EMBEDMENT, TILT, OR FIBRINOUS CAPSULE FORMATION. REPORTED COMPLICATIONS INCLUDED ONE MAJOR ADVERSE EVENT (ACUTE PULMONARY EDEMA POST-PROCEDURE REQUIRING ICU STAY) AND ONE MINOR ADVERSE EVENT (CONTAINED CAVAL PERFORATION AFTER ADHERENT FILTER RETRIEVAL).