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

Model Number	638BL26
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/10/2018
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 this 26mm mitral annuloplasty band was implanted and explanted during the same procedure.The device was replaced with a 31mm mitral bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that the reason for not using this 26mm mitral annuloplasty band was due to the patient native tissue.A 31mm mitral bioprosthetic valve was successfully implanted in its place.No additional adverse patient effects were reported. added patient weight to field.Updated device code to field.Updated evaluation code method to field.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: 7940342
• Report Number: 2025587-2018-02667
• Device Sequence Number: 19046773
• Product Code: KRH
• UDI-Device Identifier: 00613994758750
• UDI-Public: 00613994758750
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 12/12/2021
• Device Model Number: 638BL26
• Device Catalogue Number: 638BL26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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
• Patient Weight: 65