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

Model Number 638RL

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); No Information (3190)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 this annuloplasty ring in the mitral position was explanted and replaced with a bioprosthetic mitral valve approximately two years post-implant.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was explanted and replaced due to residual mitral regurgitation and calcification of the patient's annulus.The patient tolerated the replacement procedure very well and no other adverse patient effects were reported.Patient identifier added.Patient weight added.Patient's relevant medical history added.Patient and device codes updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 6664117
• MDR Text Key: 78296899
• Report Number: 2025587-2017-01031
• 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,Followup
• Report Date: 07/13/2017

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: 04/15/2020
• Device Model Number: 638RL
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 07/13/2017
• Supplement Dates FDA Received: 07/13/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2015
• 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: 61 YR
• Patient Weight: 79