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

Model Number 700FC27

Device Problem Gradient Increase (1270)

Patient Problems Mitral Valve Stenosis (1965); Stenosis (2263)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

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 Description

Medtronic received information that 1 year 6 months post implant of this 27mm mitral annuloplasty band, it was explanted and replaced with a 25mm mitral bioprosthetic valve for severe mitral stenosis along with increased gradients.No additional adverse patient effects were reported. .

Manufacturer Narrative

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

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7754178
• MDR Text Key: 116200647
• Report Number: 9612164-2018-01960
• Device Sequence Number: 0
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 700FC27
• Device Catalogue Number: 700FC27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/07/2016
• 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: 56 YR
• Patient Weight: 62