MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 24MM; RING, ANNULOPLASTY

Model Number	680R24
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Corneal Pannus (1447); Mitral Insufficiency (1963); Mitral Valve Stenosis (1965)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that three years and ten months post implant of this annuloplasty ring, the ring was explanted and replaced with a bioprosthetic valve due to pannus.The surgeon reported that the pannus caused stenosis and constriction of the leaflets with distortion and incompetence of the native valve.The surgeon reported the ring was well seated with no paravalvular leak (pvl) and that the issue was caused by the pannus.No additional adverse patient effects were reported.

• Brand Name: RING PROFILE 3D 24MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8672083
• Report Number: 2025587-2019-01828
• Device Sequence Number: 243471
• Product Code: KRH
• UDI-Device Identifier: 00613994759269
• UDI-Public: 00613994759269
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 11/02/2017
• Device Model Number: 680R24
• Device Catalogue Number: 680R24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/05/2019
• 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: 76 YR