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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY
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MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY Back to Search Results
Model Number 620BG33
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2017
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.
 
Event or Problem Description
Medtronic received information that this mitral annuloplasty band was implanted and explanted on the same day for unknown reasons.No additional adverse patient effects were reported.
 
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Brand Name
RING 620RG33 DURAN ANCORE ANNULOPLASTY C
Common Device Name
RING, ANNULOPLASTY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key6811851
Report Number2025587-2017-01454
Device Sequence Number2066520
Product Code KRH
UDI-Device Identifier00613994759146
UDI-Public00613994759146
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K032810
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/31/2017
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 Date02/17/2019
Device Model Number620BG33
Device Catalogue Number620BG33
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2017
Initial Report FDA Received Date08/22/2017
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 Age72 YR
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