MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY

Model Number 680R36

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/04/2018

Event Type  Death  

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 Description

Medtronic received information from a patient's husband that the patient died 11 days post implant of this mitral annuloplasty band.The husband reported that "the device was part of the surgery that failed".No further details were provided.It is unknown if an autopsy was performed.

• Brand Name: RING PROFILE 3D 36MM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10442980
• MDR Text Key: 204035562
• Report Number: 2025587-2020-02659
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759207
• UDI-Public: 00613994759207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 680R36
• Device Catalogue Number: 680R36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR