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

Model Number 638RL26

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.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 immediately post implant of this 26mm mitral annuloplasty ring, it was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for replacement was reported as moderate residual regurgitation.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual evaluation showed damage on the sewing cloth adjacent to the trigonal marker, likely resulting from suture placement through the eyelet.From the inflow, the sewing cloth and green suture was frayed.Radiography showed no evidence of distortion or fractures in the ring.Conclusion: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native mitral anatomy.There are times when valve repair is attempted using a repair device and subsequent post-repair evaluation demonstrates an inadequate result.This is potentially due to, but not limited to, sub-optimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CG FUTURE BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9104421
• MDR Text Key: 159610500
• Report Number: 2025587-2019-02890
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793514
• UDI-Public: 00643169793514
• Combination Product (y/n): N
• PMA/PMN Number: K061127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: 638RL26
• Device Catalogue Number: 638RL26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention