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

Model Number	620RG25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)
Date of Event	07/06/2018
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 10 years and 6 months post implant of this 25mm annuloplasty ring implanted in the mitral position, the patient presented with new york heart association (nyha) class iii symptoms (dyspnea and exercise intolerance) as well as lower extremity swelling and difficult to control pre-existing atrial fibrillation (afib).Transesophageal echocardiogram (tee) revealed mitral regurgitation and moderate stenosis.The patient subsequently underwent right and left heart catheterization at an unknown time post implant.Ultimately, 10 years and 7 months post implant of the annuloplasty ring, it was explanted and replaced with a 27mm bioprosthetic valve.During placement of the mitral valve, the native anterior leaflet was bisected and brought to the 4 and 8 o'clock position.The entire posterior leaflet and valvular structures were retained.No additional adverse patient effects were reported.  additional information was received that immediately after implant of this 26mm tricuspid annuloplasty ring, tee confirmed moderate regurgitation.No interventions or adverse patient effects were reported.
Additional Manufacturer Narrative
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: 7889228
• Report Number: 2025587-2018-02459
• Device Sequence Number: 1909141
• Product Code: KRH
• UDI-Device Identifier: 00721902859762
• UDI-Public: 00721902859762
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 09/19/2018

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: 03/08/2012
• Device Model Number: 620RG25
• Device Catalogue Number: 620RG25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: 72 YR
• Patient Weight: 92