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

Model Number	638RL28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/04/2020
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 this patient's native mitral valve was dilated and had severe regurgitation.The surgeon implanted this 28 mm mitral annuloplasty ring in attempt to repair the patient's valve.Testing with saline showed a successful repair.Upon weaning off of cardiopulmonary bypass (cpb) however, residual regurgitation was present.The patient was placed back on cpb, and the valve was replaced with a bioprosthetic valve.No additional adverse patient effects were reported.

• 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: 10792606
• Report Number: 2025587-2020-03445
• Device Sequence Number: 3680933
• Product Code: KRH
• UDI-Device Identifier: 00643169793521
• UDI-Public: 00643169793521
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: 05/20/2024
• Device Model Number: 638RL28
• Device Catalogue Number: 638RL28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/05/2020
• 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: 66 YR
• Patient Weight: 84