MAUDE Adverse Event Report: HEART VALVES SANTA ANA BAND 620BG29 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620BG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that one year, two months post implant of this annuloplasty band in the mitral position, this device was explanted and replaced with a bioprosthetic mitral valve.No failure mechanism and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received information that this annuloplasty band in the mitral position was explanted due to severe mitral regurgitation.Patient weight added;.Explant date added.

• Brand Name: BAND 620BG29 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6701570
• Report Number: 2025587-2017-01142
• Device Sequence Number: 725066
• Product Code: KRH
• UDI-Device Identifier: 00613994759108
• UDI-Public: 00613994759108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: 12/17/2020
• Device Model Number: 620BG
• Device Catalogue Number: 620BG29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/14/2017
• 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: 81 YR
• Patient Weight: 54