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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/11/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient was intended to receive a carbomedics standard m7-027 mechanical mitral heart valve.The manufacturer was notified that the valve was removed intra-operatively.No further information was received.

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 manufacturer contacted the site for further event information and was notified that no further information was available for this event.Based on the limited information the root cause of the event cannot be determined and no further investigations can be performed at this time.

• 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, vc
• MDR Report Key: 10084741
• MDR Text Key: 194811295
• Report Number: 1718850-2020-01086
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)231022
• 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: 04/23/2020,07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: M7-027
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR