MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. 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  

Manufacturer Narrative

Device evaluated by mfr: device location not presently known.

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.

Manufacturer Narrative

A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the available information, the device can be resonably excluded as a contributory factor of this event.As reported, the valve was well functioning and no mechanical issues were reported.The event can be reasonably attributed to the patient's anatomy at the time of the first implant (very small annulus in a 1-month-old-child), as also reported by the site.

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 18 june 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 (1-month-old child).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): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8848951
• MDR Text Key: 152906403
• Report Number: 3005687633-2019-00220
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO