MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; 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	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposition unknown.
Event or Problem Description
On (b)(6) 2009 a patient received a carbomedics standard m7-021 mechanical heart valve implant as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a carbomedics standard m7-027.No further information was received.
Additional Manufacturer Narrative
The manufacturer made several attempts to follow-up for further information but no further information is available at this time due to the war presently on going in armenia.At this time based on the information available there is no identification of the type of event, patient factors or adverse harm, or device related information.Because no information is available the root cause cannot be established at this time.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10485501
• Report Number: 3005687633-2020-00135
• Device Sequence Number: 4129070
• Product Code: LWQ
• UDI-Device Identifier: 08022057012692
• UDI-Public: (01)08022057012692(240)M7-021(17)121216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: Health Professional
• Device Expiration Date: 12/16/2012
• Device Model Number: CPHV
• Device Catalogue Number: M7-021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: 15 YR