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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUPLUS ANNULOPLASTY BAND; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION SIMUPLUS ANNULOPLASTY BAND; RING, ANNULOPLASTY Back to Search Results
Model Number 7700FB36
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/24/2021
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 36mm mitral annuloplasty band, it was explanted and replaced with an unknown device.The reason for the replacement was not reported.No additional adverse patient effects were reported.
 
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Brand Name
SIMUPLUS ANNULOPLASTY BAND
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key11454009
Report Number2025587-2021-00805
Device Sequence Number19631131
Product Code KRH
UDI-Device Identifier00763000271039
UDI-Public00763000271039
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K201449
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/10/2021
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 Date08/11/2025
Device Model Number7700FB36
Device Catalogue Number7700FB36
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/03/2021
Initial Report FDA Received Date03/10/2021
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 Age56 YR
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