MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION BAND 620BG27 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620BG27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	06/30/2020
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 immediately post implant of this 27mm mitral annuloplasty band, there was moderate to severe regurgitation noted.The surgeon stated that the band did not adequately repair the patient's native valve and that there was an atrial mass removed at the same time, which likely complicated the repair.A non medtronic valve was successfully implanted in its place.No additional adverse patient effects were reported. .

• Brand Name: BAND 620BG27 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: 10338864
• Report Number: 2025587-2020-02371
• Device Sequence Number: 3854216
• Product Code: KRH
• UDI-Device Identifier: 00613994759085
• UDI-Public: 00613994759085
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: 04/04/2022
• Device Model Number: 620BG27
• Device Catalogue Number: 620BG27
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: Required Intervention
• Patient Age: 43 YR