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

Model Number	638BL28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Insufficiency (1963)
Date of Event	01/08/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of this 28mm mitral annuloplasty band the physician reported the native mitral valve was very difficult to expose and place sutures in.Following implant, testing of the valve revealed no insufficiency.As the chest was being closed the valve had severe insufficiency.The patient was placed back on bypass and no specific cause for the insufficiency was found however, the anterior leaflet now appeared to be protruding over the annulus.The annuloplasty band was removed and replaced with a complete 28mm non-medtronic annuloplasty ring.The physician decided that a complete ring may help the insufficiency.Following the implant of the non-medtronic ring, insufficiency remained and the physician replaced the ring with a 27mm non-medtronic valve.No additional adverse patient effects were reported. .

• 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: 7252895
• Report Number: 2025587-2018-00335
• Device Sequence Number: 111738
• Product Code: KRH
• UDI-Device Identifier: 00613994758774
• UDI-Public: 00613994758774
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 10/17/2021
• Device Model Number: 638BL28
• Device Catalogue Number: 638BL28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/08/2018
• 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: 78 YR