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

Model Number	690R32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2021
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information that one day post implant of this tricuspid annuloplasty device, the patient passed away.The cause of death was not reported.There is no information to suggest the medtronic device caused or contributed to the death.It is unknown if an autopsy was performed.
Additional Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.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.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12851786
• Report Number: 2025587-2021-03521
• Device Sequence Number: 17353504
• Product Code: KRH
• UDI-Device Identifier: 00643169121706
• UDI-Public: 00643169121706
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 03/25/2024
• Device Model Number: 690R32
• Device Catalogue Number: 690R32
• 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: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 04/15/2019
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male