MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING 620RG25 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620RG25

Device Problems Material Separation (1562); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 11/18/2020

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 5 years and 20 days post implant of this 25mm mitral annuloplasty ring, it was explanted and replaced with a 27mm mitral bioprosthetic valve.It was reported that the ring had become too small for the patient and was causing mitral stenosis.It was also reported that the anterior annular part of the ring was detached from the mitral annulus.No additional adverse patient effects were reported. .

• Brand Name: RING 620RG25 DURAN ANCORE ANNULOPLASTY C
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11055861
• MDR Text Key: 223150015
• Report Number: 2025587-2020-03908
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758927
• UDI-Public: 00613994758927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• 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
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2018
• Device Model Number: 620RG25
• Device Catalogue Number: 620RG25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Date Device Manufactured: 05/09/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 89