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

Model Number	638RL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/27/2017
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 this 30 mm mitral annuloplasty ring was implanted and explanted during the same procedure and replaced with a 29 mm mitral bioprosthetic valve for unknown reasons.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that this device was not used due to what the physician believed to be restriction of the posterior leaflet, the coaptation plane was made up of very thin leaflet tissue on both the anterior and posterior leaflets.They physician did not feel that an adequate coaptation depth with healthy leaflet tissue would be likely and elected to replace the ring with a 29mm bioprosthetic valve instead.No additional adverse patient effects were reported.  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 VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7046032
• Report Number: 2025587-2017-02211
• Device Sequence Number: 2144298
• Product Code: KRH
• UDI-Device Identifier: 00613994758651
• UDI-Public: 00613994758651
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/20/2017

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: 638RL
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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: 76 YR
• Patient Weight: 83