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

Model Number	690R34
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during implantation of the ring annuloplsty tricusp contour 3d 34mm, tricuspid repair failure occurred and the ring was explanted.No patient complications have been reported as a result of this event.
Event or Problem Description
Additional information was received that post repair using this 34mm annuloplasty ring, the native valve leaflet did not coapt properly leading to regurgitation.It was stated that the annuloplasty ring was fully sutured and tested prior to removal.It was reported that the 34mm annuloplasty ring did not malfunction and no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
B5 and h6 updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the ring was attached to the holder with a blue monofilament suture.The ring showed slight discoloration from blood contact along the edges of the suture line.The holder was removed for further observation.Small holes were noted on the fabric; appeared to be from the holder sutures.There was no evidence of fraying or tears to the ring.Radiography showed no evidence of fractures on the stiffener.D9: updated.H3: device evaluated? updated h6: updated the codes medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 22128132
• Report Number: 2025587-2025-04008
• Device Sequence Number: 7343426
• Product Code: KRH
• UDI-Device Identifier: 00643169121713
• UDI-Public: (01)00643169121713(17)290123(21)J167797
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 690R34
• Device Catalogue Number: 690R34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 09/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/05/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown