MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638B
Medical Device Problem Codes	Incomplete Coaptation (2507); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Regurgitation (1964); No Information (3190)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, but no new information has been received.The device has not been received for analysis.Without the receipt 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 5 years and 11 months post implant of this annuloplasty band in the mitral position, it was explanted and replaced with a bioprosthetic valve.No failure mechanism was provided.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received indicating that this annuloplasty band was explanted and replaced due to severe mitral regurgitation, secondary to posterior leaflet restriction and anterior leaflet coaptation failure.This patient was symptomatic with dyspnea and elevated pulmonary pressures.No other adverse patient effects were reported.This product is not available for return.
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: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6354959
• Report Number: 2025587-2017-00309
• Device Sequence Number: 433324
• Product Code: KRH
• UDI-Device Identifier: 00613994751805
• UDI-Public: 00613994751805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2017

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: 11/01/2015
• Device Model Number: 638B
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided; 02/08/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/08/2017; 09/29/2017
• 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: 69 YR
• Patient Weight: 106