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

Model Number	620RG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	02/09/2018
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 approximately 5 years and 8 months post implant of this mitral annuloplasty ring, the ring was explanted and replaced with a bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that this annuloplasty ring was explanted and replaced with a bioprosthetic valve due to thickened leaflets, a dilated inner annulus, and severe mitral regurgitation.If information is provided in the future, a supplemental report will be issued.

• 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: 7323135
• Report Number: 2025587-2018-00511
• Device Sequence Number: 13490506
• Product Code: KRH
• UDI-Device Identifier: 00613994758927
• UDI-Public: 00613994758927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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 Date: 05/03/2017
• Device Model Number: 620RG
• Device Catalogue Number: 620RG25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68