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

Model Number	638RL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return 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 or Problem Description
Medtronic received information that this mitral annuloplasty ring was implanted and explanted during the same procedure.After implant the physician observed a large leak as the patients annulus was too large for the ring.The ring was then explanted and replaced with a mitral bioprosthetic valve.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that this mitral annuloplasty ring was implanted and explanted during the same procedure.A post implant transesophageal echocardiogram (tee) was performed which revealed a significant leak.The physician determined that the patient's annulus was too large for the 32 mm ring.The 32 mm ring was then explanted and replaced with a 29 mm mitral bioprosthetic valve.Another transesophageal echocardiogram (tee) was performed, which showed good functioning of the valve.No additional adverse patient effects were reported.Conclusion: the physician determined that the patient¿s annulus was too large for the 32 mm ring.The 32 mm ring was then explanted and replaced with a 29 mm mitral bioprosthetic valve.The event appears to be due to sizing.There is no indication that the event was due to the manufacture of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6891366
• Report Number: 2025587-2017-01680
• Device Sequence Number: 16331283
• Product Code: KRH
• UDI-Device Identifier: 00613994758675
• UDI-Public: 00613994758675
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 06/07/2021
• Device Model Number: 638RL
• Device Catalogue Number: 638RL32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: 48 YR
• Patient Weight: 64