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

Model Number CPHV

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 09/23/2017

Event Type  Injury  

Manufacturer Narrative

According to the event narrative provided, the size of the implanted device was inappropriate for the patient, and the event was therefore not device-related.As such, no further investigation is warranted at this time.Device not available for return.

Event Description

It was reported that an optiform prosthetic mitral heart valve f7-023 was explanted due to patient-prosthesis mismatch.The 23 mm optiform was reportedly too small for the patient.The valve was explanted and a 25 mm st.Jude mechanical valve was implanted.The patient had a normal recovery, and was dismissed from the hospital on schedule.There was no qa issue with the valve.The device was not available for analysis.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7135581
• MDR Text Key: 95408219
• Report Number: 3005687633-2017-00138
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012838
• UDI-Public: (01)08022057012838(240)F7-023(17)151011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/11/2015
• Device Model Number: CPHV
• Device Catalogue Number: F7-023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR