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

Model Number	638RL28
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: 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 eight years and eleven months post implant of this 28mm mitral annuloplasty ring, the ring was explanted and replaced with a 27mm bioprosthetic valve.The indication for replacement was severe regurgitation and moderate stenosis.Examination of the native mitral valve revealed thickened anterior and posterior leaflets.The posterior leaflet appeared retracted, and the surgeon felt this was contributing to the insufficiency.During the replacement procedure, a trapezoid portion of the anterior leaflet was resected, and the posterior leaflet was retained.Additionally, the native tricuspid valve was repaired with an annuloplasty ring.Post-operative transesophageal echocardiogram (tee) demonstrated mild mitral insufficiency and trivial tricuspid insufficiency.No additional interventions took place, and no additional adverse patient effects were reported. .

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7943244
• Report Number: 2025587-2018-02674
• Device Sequence Number: 19168344
• Product Code: KRH
• UDI-Device Identifier: 00613994521057
• UDI-Public: 00613994521057
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 06/24/2014
• Device Model Number: 638RL28
• Device Catalogue Number: 638RL28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/08/2018
• 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: 81 YR
• Patient Weight: 77