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

Model Number	CPHV
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7135581
• Report Number: 3005687633-2017-00138
• Device Sequence Number: 1211111
• Product Code: LWQ
• UDI-Device Identifier: 08022057012838
• UDI-Public: (01)08022057012838(240)F7-023(17)151011
• Combination Product (Y/N): N
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Physician
• Device Expiration Date: 10/11/2015
• Device Model Number: CPHV
• Device Catalogue Number: F7-023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR