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

Model Number 638RL30

Device Problems Gradient Increase (1270); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); Fibrosis (3167); No Information (3190)

Event Date 05/14/2018

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 5 years post implant of this mitral annuloplasty ring, the ring was explanted and replaced with bioprosthetic valve. the reason for the explant was not reported.  no additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the mitral annuloplasty ring was replaced due to moderate mitral stenosis with a mean gradient between 8 and 12 mmhg.It was reported the mitral valve was thickened, not very pliable, and demonstrated significant fibrosis, specifically at the previous alfieri stitch.The ring was successfully replaced and no additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.

• Brand Name: CG FUTURE 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 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: 8009477
• MDR Text Key: 125149288
• Report Number: 2025587-2018-02850
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758651
• UDI-Public: 00613994758651
• 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,Followup
• Report Date: 12/10/2018

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: 02/06/2018
• Device Model Number: 638RL30
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 12/10/2018
• Date Device Manufactured: 02/18/2013
• 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: 69 YR