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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL
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MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 505DM26
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2021
Event Type  Injury  
Event Description
Medtronic received information that during the implant of this 26mm mechanical valve, it was explanted and replaced with a non medtronic product.The reason for the replacement was not reported. no additional adverse patient effects were reported.
 
Manufacturer Narrative
Product analysis: no product was returned.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.
 
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Brand Name
OPEN PIVOT AP360 HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
Manufacturer (Section G)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12911146
MDR Text Key281532426
Report Number3008592544-2021-00044
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P990046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number505DM26
Device Catalogue Number505DM26
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2021
Date Device Manufactured03/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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