MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM; RING, ANNULOPLASTY

Model Number	690R28
Medical Device Problem Codes	Particulates (1451); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tricuspid valve repair procedure, a white foreign object was found inside the packaging of the 28mm contour 3d heart ring.The foreign object was removed under sterile conditions.Due to safety concerns, the annuloplasty ring was not implanted and was replaced by another manufacturer's product.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Updated data: b.5: event description.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
Additional information was received that reported the foreign object looked to be made of suture material.It was further noted that that the object was found on the annuloplasty ring within the packaging.No additional adverse patient effects were reported.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24092290
• Report Number: 9617601-2026-00323
• Device Sequence Number: 16051583
• Product Code: KRH
• UDI-Device Identifier: 00643169121683
• UDI-Public: (01)00643169121683(17)300110
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 690R28
• Device Catalogue Number: 690R28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/22/2026
• Date Device Manufactured: 01/11/2025
• 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
• Patient Sex: Unknown