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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

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MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
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.
 
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Brand Name
OPEN PIVOT MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
Manufacturer (Section G)
MEDTRONIC STRUCTURAL HEART
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key4878585
MDR Text Key6046670
Report Number3008592544-2015-00028
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 09/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/27/2017
Device Model Number500
Device Catalogue Number500DM29
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2015
Initial Date FDA Received06/30/2015
Supplement Dates Manufacturer Received09/30/2015
Supplement Dates FDA Received09/18/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/27/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age00048 YR
Patient Weight111
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