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

Model Number	638RL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis pending.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 after implant of this mitral annuloplasty ring, the physician was not satisfied with the competency of the valve.The device was explanted and replaced with a non-medtronic mechanical valve during the same position.The physician stated that there was no failure of the device but rather that he misjudged the repairability of the native tissue.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, radiography showed no evidence of distortion or fractures in the ring.The device history record was not reviewed as the event description does not indicate a potential manufacturing issue.Surgeons often attempt to repair mitral valves in lieu of replacing them due to improved long term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates inadequate results.This is often due to sub-optimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the device.In this case, medtronic received information that after implant of this mitral annuloplasty ring, the physician was not satisfied with the competency of the valve.The physician stated that there was no failure of the device but rather that he misjudged the repairability of the native tissue.No anomalies were noted on the device during analysis.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: 6872186
• Report Number: 2025587-2017-01617
• Device Sequence Number: 19138070
• Product Code: KRH
• UDI-Device Identifier: 00613994758675
• UDI-Public: 00613994758675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061127
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 05/17/2021
• Device Model Number: 638RL
• Device Catalogue Number: 638RL32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 44 YR