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

Model Number 638B

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Insufficiency (1963); Obstruction/Occlusion (2422)

Event Date 05/23/2015

Event Type  Injury  

Event Description

Medtronic received information that 11 days post implant of this mitral bioprosthetic annuloplasty band, it was explanted and replaced with a non-medtronic device due to developed mitral valve insufficiency, systolic anterior mitral leaflet, and left ventricular outflow tract obstruction.No other adverse patient effects were reported.

Manufacturer Narrative

The device has not been returned.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Conclusion: this event does not indicate a potential manufacturing issue.Based on historical data, failed repairs are likely due to the patient¿s native anatomy.

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4913813
• MDR Text Key: 21833519
• Report Number: 2025587-2015-00742
• Device Sequence Number: 1
• Product Code: KRH
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2015

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: 08/11/2019
• Device Model Number: 638B
• Device Catalogue Number: 638BL36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: 08/14/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2014
• 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: 00062 YR