MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number 638RL28

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 09/10/2018

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 eight years and eleven months post implant of this 28mm mitral annuloplasty ring, the ring was explanted and replaced with a 27mm bioprosthetic valve.The indication for replacement was severe regurgitation and moderate stenosis.Examination of the native mitral valve revealed thickened anterior and posterior leaflets.The posterior leaflet appeared retracted, and the surgeon felt this was contributing to the insufficiency.During the replacement procedure, a trapezoid portion of the anterior leaflet was resected, and the posterior leaflet was retained.Additionally, the native tricuspid valve was repaired with an annuloplasty ring.Post-operative transesophageal echocardiogram (tee) demonstrated mild mitral insufficiency and trivial tricuspid insufficiency.No additional interventions took place, and no additional adverse patient effects were reported. .

• Brand Name: CG FUTURE 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: 7943244
• MDR Text Key: 123049062
• Report Number: 2025587-2018-02674
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994521057
• UDI-Public: 00613994521057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061127
• 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
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2014
• Device Model Number: 638RL28
• Device Catalogue Number: 638RL28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Date Device Manufactured: 07/27/2009
• 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: 81 YR
• Patient Weight: 77