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

Model Number	638BL
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7045113
• Report Number: 2025587-2017-02195
• Device Sequence Number: 16172595
• Product Code: KRH
• UDI-Device Identifier: 00613994758774
• UDI-Public: 00613994758774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: 638BL
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR