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

Model Number	800SR
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/19/2017
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 procedure to implant this 26mm annuloplasty ring, the ring was explanted and replaced.The physician stated the size of the ring was too big to adequately shrink annulus for proper coaptation of leaflets and did not resolve the mitral regurgitation (mr).(1) mick et al, ann cardiothorac surg 2015; 4(3):230-237.
Event or Problem Description
Medtronic received information that during the procedure to implant this 26mm annuloplasty ring, the ring was explanted and replaced.The physician stated the size was too big to adequately shrink annulus for proper coaptation of leaflets and did not resolve the mitral regurgitation (mr).No adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6944688
• Report Number: 2025587-2017-01825
• Device Sequence Number: 891607
• Product Code: KRH
• UDI-Device Identifier: 00643169182103
• UDI-Public: 00643169182103
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 10/12/2017

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: 08/31/2021
• Device Model Number: 800SR
• Device Catalogue Number: 800SR26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement 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: 64 YR