MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number M7-025

Device Problems Fracture (1260); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, the valve was reportedly "tight" and a valve leaflet fell off during the adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.

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.The device is being returned to the manufacturer and further investigation will be performed upon receipt.

Manufacturer Narrative

After decontamination, the visual inspection performed on the returned valve confirmed the absence of pre-existing manufacturing defects.The dimensional verification of the implant diameter of the returned prosthesis confirmed the compliance with the specifications for a carbomedics standard mitral #25.Based on the performed analysis, the event reported from the field cannot be explained by any pre-existing factor intrinsic in the involved device.A possible reason for the observed incomplete leaflet mobility may be reasonably associated with interference with native anatomical structures.

Event Description

On (b)(6) 2019, a carbomedics standard mitral m7-025 was intended for a mitral valve replacement.During the implantation, it was reported that one of the leaflets did not move smoothly, and reportedly 'got stuck' somehow.It was attempted to adjust it, but then the leaflet fell off during adjustment.A new valve of the same model was immediately replaced.The procedure was successfully completed with the new m7-025 and the patient had a good outcome after surgery.No perceived issues with the device were reported before the implant.

Manufacturer Narrative

The device was returned to the manufacturer and it was received on 23 dec 2019.The device was received with a leaflet disassembled and broken.Further investigation is ongoing and the results will be submitted upon completion.

• 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: 9392075
• MDR Text Key: 168781930
• Report Number: 3005687633-2019-00265
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012715
• UDI-Public: (01)08022057012715(240)M7-025(17)230224
• 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,Followup,Followup
• Report Date: 01/30/2020

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: 02/24/2023
• Device Model Number: M7-025
• Device Catalogue Number: M7-025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/29/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 12/23/2019; 01/19/2020
• Supplement Dates FDA Received: 12/31/2019; 01/18/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention