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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVE DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 500DM23
Device Problem Incomplete Coaptation (2507)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately 11 months post implant of this mitral mechanical valve, it was explanted and replaced with a 25mm mitral bioprosthetic valve due to the mechanical leaflet was not opening properly.Once the mechanical valve was explanted it was inspected and the leaflets appeared to be working appropriately.No additional adverse patient effects were reported. .
 
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Brand Name
OPEN PIVOT MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
3800 annapolis lane
minneapolis MN 55447
Manufacturer (Section G)
MEDTRONIC HEART VALVE DIVISION
3800 annapolis lane
minneapolis MN 55447
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key7896644
MDR Text Key120960858
Report Number3008592544-2018-00039
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P990046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/20/2018
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 Model Number500DM23
Device Catalogue Number500DM23
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/03/2018
Initial Date FDA Received09/20/2018
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;
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