|
Model Number 500 |
Device Problems
Gradient Increase (1270); Incomplete Coaptation (2507)
|
Patient Problems
Corneal Pannus (1447); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Thrombus (2101)
|
Event Date 05/26/2015 |
Event Type
Injury
|
Event Description
|
Medtronic received information that this mechanical valve in the mitral position was explanted and replaced with a tissue bioprosthetic valve approximately two years post implant due to one of the valve leaflets being stuck in the closed position; this patient was non-compliant with their warfarin treatment.The patient presented with shortness of breath, mitral stenosis, pulmonary hypertension, and elevated gradients.Upon explant, visual inspection of the valve showed chronic, as well as fresh, thrombus, and pannus in-growth on both the atrial and ventricular side of the valve around the leaflet which was frozen and non-functional.Following the procedure, the patient was transferred to the intensive care unit (icu) in critical condition.No other adverse patient effects were reported.
|
|
Manufacturer Narrative
|
The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).
|
|
Manufacturer Narrative
|
Based on the received information, the high gradient / stenosis was due to the leaflet motion.The leaflet motion was caused by thrombus and pannus; and the thrombus formation most likely was due to patient non-compliance with their warfarin treatment.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|