MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION BAND 620BG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620B
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, but no new information has been received to date.The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that immediately following implant of this 31mm annuloplasty band, this band was explanted and replaced with a 29mm band.No failure mode and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this annuloplasty band in the mitral position was replaced after the repair failed due to severe regurgitation.The physician confirmed that there were no patient complications resulting from this procedure.
Additional Manufacturer Narrative
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.

• Brand Name: BAND 620BG31 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: 6137362
• Report Number: 2025587-2016-01888
• Device Sequence Number: 1128906
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2017

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: 05/04/2021
• Device Model Number: 620B
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided; 01/05/2017
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 01/05/2017; 09/27/2017
• 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: 57 YR
• Patient Weight: 99