MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING 620RG25 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG25
Medical Device Problem Codes	Material Separation (1562); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	11/18/2020
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 5 years and 20 days post implant of this 25mm mitral annuloplasty ring, it was explanted and replaced with a 27mm mitral bioprosthetic valve.It was reported that the ring had become too small for the patient and was causing mitral stenosis.It was also reported that the anterior annular part of the ring was detached from the mitral annulus.No additional adverse patient effects were reported. .

• Brand Name: RING 620RG25 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11055861
• Report Number: 2025587-2020-03908
• Device Sequence Number: 3206773
• Product Code: KRH
• UDI-Device Identifier: 00613994758927
• UDI-Public: 00613994758927
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• 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): 12/22/2020

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 Date: 05/02/2018
• Device Model Number: 620RG25
• Device Catalogue Number: 620RG25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 89