MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	700FC29
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 6 months post implant of this 29mm mitral annuloplasty band, it was explanted and replaced with a 27mm mitral bioprosthetic valve.The reason for the replacement was reported as recurrent mitral insufficiency.It was also reported that the "stiches between a3 and p3 were torn" and that there was a torn leaflet.No additional adverse patient effects were reported.
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.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13206587
• Report Number: 2025587-2022-00063
• Device Sequence Number: 11899441
• Product Code: KRH
• UDI-Device Identifier: 00643169182387
• UDI-Public: 00643169182387
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K052899
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

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: 11/18/2025
• Device Model Number: 700FC29
• Device Catalogue Number: 700FC29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG