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

Model Number	700FC33
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); No Information (3190)
Date of Event	10/10/2018
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 immediately after implant of this 33mm mitral annuloplasty band, it was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for explant is unknown.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received additional information that that the reason for immediate removal of the 33mm mitral annuloplasty band was it failed to repair the patients native tissue and post implant showed continued moderate regurgitation.As a result the band was removed and the patients native valve replaced with a non medtronic valve.No additional adverse patient effects were reported. 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
• MDR Report Key: 8052523
• Report Number: 2025587-2018-03005
• Device Sequence Number: 1787758
• Product Code: KRH
• UDI-Device Identifier: 00643169182363
• UDI-Public: 00643169182363
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 12/01/2022
• Device Model Number: 700FC33
• Device Catalogue Number: 700FC33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 68 YR
• Patient Weight: 62