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 Insufficiency (1963); Mitral Valve Prolapse (2471)
Date of Event	10/16/2020
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 post implant of this 33mm mitral annuloplasty band, insufflation of the ventricle showing continued mild mitral valve prolapse with no leak.The patient was weaned off cardiopulmonary bypass (cpb) and transesophageal echocardiogram showed systolic anterior motion of the mitral valve with moderate insufficiency.The patient was put back on cpb and the 33mm annuloplasty band was removed and replaced with a 37mm annuloplasty band.No additional adverse patient effects were reported.

• 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: 10743594
• Report Number: 2025587-2020-03240
• Device Sequence Number: 11737205
• Product Code: KRH
• UDI-Device Identifier: 00643169182363
• UDI-Public: 00643169182363
• 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: 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): 10/27/2020

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: 01/08/2025
• Device Model Number: 700FC33
• Device Catalogue Number: 700FC33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/27/2020
• 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: 72 YR