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

Model Number	638BL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/15/2016
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.
Event or Problem Description
Medtronic received information that this annuloplasty band was implanted and explanted on the same day.The reason for explant is unknown.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that after the device was implanted, the patient had continued regurgitation.There was no failure of the device, rather the patient's native tissue was too damaged to repair.No further adverse patient effects were reported.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.
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): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6152424
• Report Number: 2025587-2016-01951
• Device Sequence Number: 376314
• Product Code: KRH
• UDI-Device Identifier: 00613994758798
• UDI-Public: 00613994758798
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• 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): 01/11/2017

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: 05/03/2021
• Device Model Number: 638BL
• Device Catalogue Number: 638BL30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; 01/11/2017
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 01/11/2017; 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: 77 YR