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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 26MM; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 26MM; RING, ANNULOPLASTY Back to Search Results
Model Number 680R
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Mitral Regurgitation (1964)
Date of Event 02/13/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 6 years 7 months post implant of this 26mm mitral annuloplasty ring was explanted and replaced with a 27mm mitral bioprosthetic valve due to mitral regurgitaton.There were no additional adverse patient effects reported.
 
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Brand Name
RING PROFILE 3D 26MM
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVE DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7354712
Report Number2025587-2018-00630
Device Sequence Number2023994
Product Code KRH
UDI-Device Identifier00613994759252
UDI-Public00613994759252
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K073324
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2018
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 Date01/24/2016
Device Model Number680R
Device Catalogue Number680R26
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2018
Initial Report FDA Received Date03/20/2018
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 Age75 YR
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