MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTOUR 3D; RING, ANNULOPLASTY

Model Number	690R26
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
Medtronic received information from the patient that 7 years and 11 months post implant of this 26mm tricuspid annuloplasty ring, it was reported that the patient was experiencing an issue with one of her leads which was causing an issue with the annuloplasty product.The patient was feeling ill and a x-ray scan was performed which showed a right atrial or right ventricular lead dangling and hanging out inside her heart near the tricuspid valve is one causing all the issue with the annuloplasty product.It was mentioned that the patient had a procedure in 5 months prior to close a hole in the heart and it was indicated that the dangling lead was not noted at that time. it was noted that the physician informed the patient that the pacemaker "is doing all the work" and the patient also mentioned that there is an "extreme leak on right side and large sized ball," and "all organs on right side of heart are a mess" as a result and the patient has already had open heart surgery twice.It was further reported that the patient is now being evaluated for another transcatheter valve- in-valve replacement procedure which is newly approved. no additional adverse patient effects were reported.

• Brand Name: CONTOUR 3D
• Common Device Name: 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18912789
• Report Number: 2025587-2024-01687
• Device Sequence Number: 6769738
• Product Code: KRH
• UDI-Device Identifier: 00643169121676
• UDI-Public: 00643169121676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: 11/14/2020
• Device Model Number: 690R26
• Device Catalogue Number: 690R26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/15/2024
• Date Device Manufactured: 12/22/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female