MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	05/30/2019
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 during the implant of this mitral valve annuloplasty ring, implanted to repair severe mitral regurgitation, saline testing post implant revealed no residual regurgitation.The patient was removed from cardiopulmonary bypass (cpb).At that time, intraoperative transesophageal echocardiogram (tee) demonstrated 2+ mitral valve regurgitation.The patient was placed back on cpb, the annuloplasty ring was explanted, and a bioprosthetic valve was implanted.No additional adverse patient effects were reported. .

• Brand Name: RING 620RG31 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 Key: 8730512
• Report Number: 2025587-2019-02028
• Device Sequence Number: 16803637
• Product Code: KRH
• UDI-Device Identifier: 00643169793408
• UDI-Public: 00643169793408
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: 09/18/2023
• Device Model Number: 620RG31
• Device Catalogue Number: 620RG31
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/25/2019
• 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: 70 YR