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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

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MEDTRONIC HEART VALVE DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY Back to Search Results
Model Number 800SR30
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Mitral Regurgitation (1964); No Information (3190)
Event Date 11/20/2019
Event Type  Injury  
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.
 
Event Description
Medtronic received information that immediately post implant of this 30mm mitral annuloplasty ring, it was explanted and replaced with a 29mm bioprosthetic valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Medtronic received additional information that the 30mm mitral annuloplasty ring was replaced due to regurgitation remaining post im plant.It was reported the patient's native valve was unable to be repaired and there was no problem with the annuloplasty ring.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SIMULUS SEMI-RIGID ANNULOPASTY RING
Type of Device
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key9503997
MDR Text Key172234316
Report Number2025587-2019-03845
Device Sequence Number1
Product Code KRH
UDI-Device Identifier00643169182288
UDI-Public00643169182288
Combination Product (y/n)N
PMA/PMN Number
K090428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/15/2020
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 Date06/26/2024
Device Model Number800SR30
Device Catalogue Number800SR30
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received12/20/2019
Supplement Dates FDA Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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