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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUFORM SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION SIMUFORM SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY Back to Search Results
Model Number 7800RR28
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Mitral Regurgitation (1964)
Date of Event 09/16/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Medtronic received information that during the implant of this 28mm mitral annuloplasty ring, it was explanted and replaced with a 31mm bioprosthetic valve.The reason for the replacement was reported as residual mitral regurgitation.No additional adverse patient effects were reported.
 
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Brand Name
SIMUFORM SEMI-RIGID ANNULOPLASTY RING
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key10694485
Report Number2025587-2020-03140
Device Sequence Number2961901
Product Code KRH
UDI-Device Identifier00763000271183
UDI-Public00763000271183
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K201449
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/16/2020
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
Operator of Device Health Professional
Device Expiration Date07/11/2025
Device Model Number7800RR28
Device Catalogue Number7800RR28
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/16/2020
Initial Report FDA Received Date10/16/2020
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;
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