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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIMPLICI-T BAND; HEART-VALVE, NON-ALLOGRAFT TISSUE
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SIMPLICI-T BAND; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number 670100
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/13/2021
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 4 years and 4 months post implant of this mitral annuloplasty band, it was explanted and replaced with a 31mm mitral bioprosthetic valve. the reason for the replacement was not reported.No additional adverse patient effects were reported.
 
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Brand Name
SIMPLICI-T BAND
Common Device Name
HEART-VALVE, NON-ALLOGRAFT TISSUE
MDR Report Key12752317
Report Number2025587-2021-03340
Device Sequence Number20009396
Product Code LWR
UDI-Device Identifier00613994759276
UDI-Public00613994759276
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K052970
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/04/2021
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 Date06/22/2017
Device Model Number670100
Device Catalogue Number670100
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2021
Initial Report FDA Received Date11/04/2021
Date Device Manufactured06/22/2016
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age79 YR
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