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

Model Number	620BG29
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this 29mm mitral annuloplasty ring was implanted and explanted during the same procedure.The device was replaced with a 29mm mitral bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that during the initial implant of this 29 mm mitral annuloplasty ring, the physician noted that the patients native tissue had very complex anterior and posterior leaflet repairs needed, and there was too much residual leaking from a prolapse noted in 3 of the native commissures.The physician stated that he was not willing to spend the extra clamp time which still may have lead to a future surgery.Instead the physician performed a successful beating heart mitral valve replacement.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: BAND 620BG29 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: 7167630
• Report Number: 2025587-2018-00059
• Device Sequence Number: 11131876
• Product Code: KRH
• UDI-Device Identifier: 00613994759108
• UDI-Public: 00613994759108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/23/2018

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: 05/11/2022
• Device Model Number: 620BG29
• Device Catalogue Number: 620BG29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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: 78 YR
• Patient Weight: 77