MAUDE Adverse Event Report: HEART VALVES SANTA ANA CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638RL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	05/10/2017
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.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 during the implant of this mitral annuloplasty ring, the physician noted moderate to severe persistent mitral regurgitation on transesophageal echocardiogram (tee) after the patient was taken off of cardiopulmonary bypass (cpb).The patient was placed back on cpb, and the device was successfully explanted and replaced with a bioprosthetic valve.No other adverse patient effects were reported.Patient medical history: history of recurrent migraine; temporomandibular joint syndrome; maze procedure.
Additional Manufacturer Narrative
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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6608443
• Report Number: 2025587-2017-00907
• Device Sequence Number: 628389
• Product Code: KRH
• UDI-Device Identifier: 00613994758675
• UDI-Public: 00613994758675
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061127
• 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): 05/16/2017

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: 03/23/2021
• Device Model Number: 638RL
• Device Catalogue Number: 638RL32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 74 YR