MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number	800SR36
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: surgeons often attempt to repair mitral valves in lieu of replacing them due to improved long term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates inadequate results.This is often due to suboptimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device (1).In this case, medtronic received information that during the implant of this 36mm annuloplasty ring, the physician noted that there was continued mitral regurgitation from the patients native tissue.The physician then explanted the 36mm ring and replaced it with a 31mm bioprosthetic mitral valve.The event appears to be sizing related.(1) mick et al, ann cardiothorac surg 2015; 4(3):230-237.
Event or Problem Description
Medtronic received information that during the implant of this 36mm annuloplasty ring, the physician noted that there was continued mitral regurgitation from the patients native tissue.The physician then explanted the 36mm ring and replaced it with a 31mm bioprosthetic mitral valve.No additional adverse patient effects were reported.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• MDR Report Key: 6946276
• Report Number: 2025587-2017-01834
• Device Sequence Number: 566317
• Product Code: KRH
• UDI-Device Identifier: 00643169182257
• UDI-Public: 00643169182257
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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: 12/31/2018
• Device Model Number: 800SR36
• Device Catalogue Number: 800SR36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: 70 YR
• Patient Weight: 70