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

Model Number 700

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Ischemia (1942); Mitral Regurgitation (1964)

Event Date 12/27/2015

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that immediately following implant of this 29 mm annuloplasty band in the mitral position, this band was explanted and replaced with a 31 mm bioprosthetic mitral valve.The patient presented to the hospital with acute shortness of breath and mitral regurgitation.The physician noted that the patient's native valve appeared functionally compromised due to ischemia.No adverse patient effects were reported due to the replacement procedure.

Manufacturer Narrative

Conclusion: investigation results indicated that a valve repair can be attempted using a repair device with subsequent post repair evaluation demonstrating an inadequate result.In this case, it is likely due to suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.The physician noted that the patient's native valve appeared functionally compromised due to ischemia.The native valve was subsequently replaced.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5389797
• MDR Text Key: 36885118
• Report Number: 2025587-2016-00088
• 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: 01/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 700
• Device Catalogue Number: 700FC29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Date Device Manufactured: 04/30/2015
• 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: 00063 YR