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 Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

This event was reported in a conservative manner due to unknown patient impact.It was clearly stated in the information provided that the event was attributable to mis-sizing.The event root cause is therefore reasonably attributable to user error, and no further investigation is warranted at this time.

Event Description

A carbomedics standard m7-027 valve was implanted and explanted due to mis-sizing.No other information was reported.

Manufacturer Narrative

The manufacturer received additional information indicating the patient outcome, and confirming that the event was attributable to user error.The original conclusion remains unchanged, and no further investigation is warranted.

Event Description

A carbomedics standard m7-027 was implanted and explanted intra-operatively on (b)(6) 2018.The device was replaced with a new valve of the correct size.The patient recovered according to expectations, and there was no delay resulting from the event.The event was attributed to user error.

• 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 13040 ; IT 13040
• MDR Report Key: 7949963
• MDR Text Key: 123191778
• Report Number: 3005687633-2018-00195
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012722
• UDI-Public: (01)08022057012722(240)M7-027(17)230323
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: CPHV
• Device Catalogue Number: M7-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention