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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.Not yet determined if device available.
Event or Problem Description
On (b)(6) 2017 the manufacturer received notification through patient tracking of the following event: on (b)(6) 2017 an optiform prosthetic mitral heart valve f7-027 was explanted and a new f7-027 was then implanted.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device (b)(4) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.On follow up with the hospital for further information it was determined that the implanting physician no longer works at this facility and the or staff did not have further information on this event.They were unable to provide the device or any information relating to the explant.Not available for return.

• 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: 6786851
• Report Number: 3005687633-2017-00082
• Device Sequence Number: 1565856
• Product Code: DYE
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)181004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 10/04/2017
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR