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

Model Number 638BL32

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2013

Event Type  Injury  

Manufacturer Narrative

Additional information was received from the physician's office that this mitral annuloplasty band was explanted after the patient presented in the emergency department due to dyspnea on exertion.A transthoracic echocardiogram (tte) was performed, revealing severe mitral regurgitation.The patient's operative notes did not specify any device performance allegations.(b)(4).

Event Description

Medtronic received information via a call to technical services from an mri technician (for mri instructions) regarding this annuloplasty band.The technician reported that 21 days post-implant of this band ((b)(4)), the band had been removed and a new band was implanted due to the product not working properly.No adverse patient effects were reported.Several attempts for additional information were made to the facility, however have been unsuccessful.

Manufacturer Narrative

The product was not returned for analysis and without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

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: 4756019
• MDR Text Key: 13427114
• Report Number: 2025587-2015-00527
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Model Number: 638BL32
• Device Catalogue Number: 638BL32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided; 05/13/2015
• Supplement Dates FDA Received: 05/13/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2013
• 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: 00074 YR
• Patient Weight: 49