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

Model Number 638B

Device Problems Incomplete Coaptation (2507); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); No Information (3190)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested, but no new information has been received.The device has not been received for analysis.Without the receipt 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 5 years and 11 months post implant of this annuloplasty band in the mitral position, it was explanted and replaced with a bioprosthetic valve.No failure mechanism was provided.No other adverse patient effects were reported.

Manufacturer Narrative

Additional information was received indicating that this annuloplasty band was explanted and replaced due to severe mitral regurgitation, secondary to posterior leaflet restriction and anterior leaflet coaptation failure.This patient was symptomatic with dyspnea and elevated pulmonary pressures.No other adverse patient effects were reported.This product is not available for return.

Manufacturer Narrative

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.

• 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: 6354959
• MDR Text Key: 68208372
• Report Number: 2025587-2017-00309
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994751805
• UDI-Public: 00613994751805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052860
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 638B
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2010
• 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: 106