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

Model Number	638RL38
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Insufficient Information (4580)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.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 during the initial implant of this annuloplasty mitral band, the leaflets were not coapting properly due to the chordeatendina.As a result the band was explanted and replaced with a non medtronic product.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: 12647200
• Report Number: 2025587-2021-03076
• Device Sequence Number: 1240368
• Product Code: KRH
• UDI-Device Identifier: 00613994758736
• UDI-Public: 00613994758736
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 04/20/2022
• Device Model Number: 638RL38
• Device Catalogue Number: 638RL38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/18/2021
• 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: Hospitalization; Required Intervention