MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 32MM; RING, ANNULOPLASTY

Model Number 680R32

Device Problem Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Dyspnea (1816); Inflammation (1932)

Event Date 07/08/2018

Event Type  Injury  

Manufacturer Narrative

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 8 months post implant of this 32mm mitral annuloplasty ring, the patient began having difficulty performing regular duties without feeling dizzy or light headed along with fatigue and unable to complete chores.As a result the ring was explanted and replaced with a 31mm mitral bioprosthetic valve.During the explant it was noted that the ring was almost completely detached from the annulus despite being fully secured.The physician noted that there was inflammation on the annulus and edematous adhesions.The ring was successfully replaced.No additional adverse patient effects were reported. .

Manufacturer Narrative

Corrected details in event description: medtronic received information that approximately 7 months post implant of this 32mm mitral annuloplasty ring, the patient began having difficulty performing regular duties without feeling dizzy or light headed along with fatigue and unable to complete chores.As a result 1 month later, the ring was explanted and replaced with a 31mm mitral bioprosthetic valve.During the explant it was noted that the ring was almost completely detached from the annulus despite being fully secured.The physician noted that there was inflammation on the annulus and edematous adhesions.The ring was successfully replaced.No additional adverse patient effects were reported.  corrected initial aware date to be 8-9-2018.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING PROFILE 3D 32MM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7837100
• MDR Text Key: 118896029
• Report Number: 2025587-2018-02300
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759221
• UDI-Public: 00613994759221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• 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
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: 680R32
• Device Catalogue Number: 680R32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Date Device Manufactured: 03/08/2017
• 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: 78 YR
• Patient Weight: 99