MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 30MM; RING, ANNULOPLASTY

Model Number 690R30

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Mitral Regurgitation (1964)

Event Date 03/01/2019

Event Type  Injury  

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 that immediately post implant of this 30mm mitral annuloplasty ring, it was explanted and replaced with a 31mm bioprosthetic valve.The surgeon stated that the patient's regurgitation was not able to be repaired with an annuloplasty device, and that the valve required replacement.No additional adverse patient effects were reported. .

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 30MM
• Type of Device: 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8458503
• MDR Text Key: 140117562
• Report Number: 2025587-2019-01055
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169121690
• UDI-Public: 00643169121690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 690R30
• Device Catalogue Number: 690R30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Date Device Manufactured: 05/01/2018
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 76