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

Model Number	638BL36
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Mitral Valve Prolapse (2471); No Information (3190)
Date of Event	11/14/2017
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.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 36 mm annuloplasty band, the band was explanted and replaced with a 33 mm annuloplasty band due to a sizing error.No adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that immediately post implant of this 36mm annuloplasty band, there was a small leak in the anterolateral commissure.One stitch was placed and the patient was de-aired however mitral regurgitation remained.The physician then placed extra sutures, but the regurgitation still remained.Subsequently the decision was made to replace the 36 mm band with a 33 mm non-medtronic tissue valve.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: 7112334
• Report Number: 2025587-2017-02421
• Device Sequence Number: 1932891
• Product Code: KRH
• UDI-Device Identifier: 00613994758859
• UDI-Public: 00613994758859
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 12/17/2020
• Device Model Number: 638BL36
• Device Catalogue Number: 638BL36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 04/09/2018
• 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: 62 YR