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

Model Number	638BL28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	03/28/2019
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 6 years and 10 months post implant of this mitral annuloplasty band, it was explanted and replaced with a bioprosthetic valve due severe regurgitation.During the explant procedure, the surgeon noted that the ring was intact.The patient's native posterior leaflet had been repaired previously with a suture, and now was retracted, which the surgeon stated was the cause of the severe regurgitation, not failure of the annuloplasty product.No additional adverse patient effects were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: 8620360
• Report Number: 2025587-2019-01619
• Device Sequence Number: 2117812
• Product Code: KRH
• UDI-Device Identifier: 00613994758774
• UDI-Public: 00613994758774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 01/09/2017
• Device Model Number: 638BL28
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/17/2019
• 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: 72 YR