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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION POSTERIOR ANNULOPLASTY BAND; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION POSTERIOR ANNULOPLASTY BAND; RING, ANNULOPLASTY Back to Search Results
Model Number H607M63
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/20/2020
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 4 days post implant of this mitral annuloplasty band, it was explanted and replaced with a 27mm mitral bioprosthetic valve. the reason for the replacement was not reported.No additional adverse patient effects were reported. .
 
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Brand Name
POSTERIOR ANNULOPLASTY BAND
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key10373300
Report Number2025587-2020-02523
Device Sequence Number11404956
Product Code KRH
UDI-Device Identifier00613994759177
UDI-Public00613994759177
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K960356
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) 08/06/2020
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 Date04/24/2024
Device Model NumberH607M63
Device Catalogue NumberH607M63
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2020
Initial Report FDA Received Date08/06/2020
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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