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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 500DM29
Medical Device Problem Code Perivalvular Leak (1457)
Health Effect - Clinical Code Skin Tears (2516)
Date of Event 11/06/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Medtronic received information that 9 months post implant of this 29 mm mechanical valve, the valve was explanted and replaced with a 27 mm bioprosthetic valve.The reason for the replacement was paravalvular leak (pvl) due to a suture tearing through the tissue.The valve was reported to be functioning normally.No adverse patient effects were reported.
 
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Brand Name
OPEN PIVOT MECHANICAL HEART VALVE
Common Device Name
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
MDR Report Key7088004
Report Number3008592544-2017-00064
Device Sequence Number1466463
Product Code LWQ
UDI-Device Identifier00643169335066
UDI-Public00643169335066
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P990046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/06/2017
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
Operator of Device Health Professional
Device Expiration Date06/21/2021
Device Model Number500DM29
Device Catalogue Number500DM29
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2017
Initial Report FDA Received Date12/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age47 YR
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