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

Model Number 690R32

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 04/20/2020

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 that during the implant of this 32mm tricuspid annuloplasty ring, it was explanted and replaced with an unknown product.Prior to the initial implant the patient's native tricuspid valve was in a state of severe regurgitation.After the implantation of the 32mm ring, moderate regurgitation remained.Therefore, the ring was replaced with a smaller size ring of the same model in order to achieve a state of no regurgitation.No additional adverse patient effects were reported. .

• Brand Name: CONTOUR 3D
• 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: 10025109
• MDR Text Key: 189906111
• Report Number: 2025587-2020-01559
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169121706
• UDI-Public: 00643169121706
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 690R32
• Device Catalogue Number: 690R32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/05/2020
• Date Device Manufactured: 09/28/2018
• 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