MAUDE Adverse Event Report: LIVANOVA CANADA CORP CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number M7-016

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Left Ventricular Dysfunction (1947); No Information (3190)

Event Date 06/18/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a patient received a carbomedics standard size 16 (m7-016, sn # (b)(4)) in mitral position.On (b)(6) 2019, the device was explanted and replaced with another m7-016, sn (b)(4).No other information is available.

Event Description

On (b)(6) 2019, a patient (one-month-old) received a carbomedics standard size 16 (m7-016, sn # (b)(6)) in mitral position.On (b)(6) 2019, the device was explanted.Based on the surgeon's assessment, the re-do surgery was not due to mechanical problems with the device, but because of the anatomical proportion of the very small patient's heart.The device was explanted due to a left ventricular dysfunction based on high (supra-annular) position of the prosthesis in a very small annulus (young patient).After the first procedure, the ventricle became larger under the prosthesis and mitral ring.The explanted valve was replaced with another m7-016, this time implanted nearly at the annulus level almost (2-3 mm above the annulus).There was no perceived issue with the explanted m7-016, which was reportedly well-functioning before the explant.During the surgery, the sinus defect closure and the right atrium plastic patch were also performed.After the re-do surgery, the patient is very well and still at the hospital to optimize anticoagulation therapy.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): LIVANOVA CANADA CORP; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8848933
• MDR Text Key: 152908517
• Report Number: 1718850-2019-01059
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/17/2019,09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: M7-016
• Device Catalogue Number: M7-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO