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

Model Number 800SR32

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen was requested; however, the medical institution refused return.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.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.

Event Description

Medtronic received information that on the day of implant of this mitral annuloplasty ring, the device was implanted and explanted during the same procedure.After the device was sutured into place, the physician noted that the leaflets would not coapt properly resulting in mild to moderate mitral regurgitation as measured on echocardiogram.The physician stated that this was due to the patient anatomy and not a malfunction of the device.No further adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Type of Device: 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5661131
• MDR Text Key: 45347903
• Report Number: 2025587-2016-00738
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 800SR32
• Device Catalogue Number: 800SR32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR