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

Model Number 638B

Device Problem Incomplete Coaptation (2507)

Patient Problems Calcium Deposits/Calcification (1758); Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that immediately following implant of this annuloplasty ring, it was explanted and replaced due to severe mitral regurgitation and dyspnea on exertion.Intraoperatively, a dilated annulus, calcification, and stiff leaflets were observed.Another partial ring was implanted to correct the leak.No further adverse patient effects were reported.

Manufacturer Narrative

Surgeons often attempt to repair valves in lieu of replacing them due to improved long term clinical outcomes.There are occurrences when a valve repair is attempted using an annuloplasty device and subsequent post repair evaluation demonstrates an inadequate result.This may likely be due to suboptimal anatomy, surgical technique or inappropriate sizing and not a malfunction of the annuloplasty ring.In this case, there was regurgitant jet prior intervention.Hardening/calcification of the native leaflets and a cleft observed between p2 and p3 segments of the leaflets were also observed.Upon placing the ring, residual mitral regurgitation was observed during testing of the valve.The cleft was repaired with interrupted sutures.Again, residual leak was noted and it was reported that it was likely due to the overcorrection and undersizing of the annulus.The surgeon opted to remove the ring and replaced it with a 30mm band with a larger ap diameter.No residual leaks were noted.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5679734
• MDR Text Key: 45936446
• Report Number: 2025587-2016-00770
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D031411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: 638B
• Device Catalogue Number: 638BL30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 83