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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 32MM; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 32MM; RING, ANNULOPLASTY Back to Search Results
Model Number 690R32
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Tricuspid Regurgitation (2112)
Date of Event 12/29/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 four years post implant of this 32 mm annuloplasty ring in the tricuspid position, it was explanted and replaced with a 33 mm bioprosthetic valve due to tricuspid regurgitation and tethering of the leaflets.No further adverse patient effects were reported.
 
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Brand Name
RING ANNULOPLSTY TRICUSP CONTOUR 3D 32MM
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key7264617
Report Number2025587-2018-00356
Device Sequence Number1222872
Product Code KRH
UDI-Device Identifier00613994845351
UDI-Public00613994845351
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K101212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/12/2018
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 Date01/21/2016
Device Model Number690R32
Device Catalogue Number690R32
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2018
Initial Report FDA Received Date02/12/2018
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 Age57 YR
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