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

Model Number 638R

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

Patient Problems Fatigue (1849); Mitral Insufficiency (1963); No Information (3190)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that approximately one year, six months post implant of this annuloplasty ring in the mitral position, this ring was explanted and replaced with a bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was replaced due to increasing mitral insufficiency.Prior to the device replacement, the patient complained of progressive fatigue.No other adverse patient effects were reported.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.

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: 6540760
• MDR Text Key: 74302876
• Report Number: 2025587-2017-00729
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758712
• UDI-Public: 00613994758712
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Model Number: 638R
• Device Catalogue Number: 638RL36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2015
• 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: 69 YR
• Patient Weight: 81