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

Model Number 638BL

Device Problem Perivalvular Leak (1457)

Patient Problem Mitral Regurgitation (1964)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this 28 mm mitral bioprosthetic band was implanted and explanted during the same procedure.Post implant of the 28 mm, after tied and sutured into place, the physician noted that the leaflets coapted well and there was essentially no regurgitation.A post implanted transesophageal echocardiogram (tee) was done which showed visually the valve looked completely normal, once a doppler was placed on the valve, it was evident that although improved, there was significant mitral regurgitation and the anterior leaflet appeared to be leaking, but the posterior leaflet was not prolapsing.The physician decided that there was too much regurgitation to leave the band in place, so the patient was placed back on bypass.The 28 mm band was removed and successfully replaced with a 29 mm bioprosthetic valve.No additional adverse patient effects were reported.

• Brand Name: CG FUTURE BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7045113
• MDR Text Key: 92502307
• Report Number: 2025587-2017-02195
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758774
• UDI-Public: 00613994758774
• 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
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: 638BL
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Date Device Manufactured: 04/11/2016
• 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: 70 YR